Document 6540987

EXHIBIT 2-2
INVESTIGATIONS OPERATIONS MANUAL 2013
INTERROGATION: ADVICE OF RIGHTS
YOUR RIGHTS
Place ________________
Date _________________
Time _________________
Before we ask you any questions, you must understand your rights.
You have the right to remain silent.
Anything you say can be used against you in court.
You have the right to talk to a lawyer for advice before we ask you any questions and
to have him with you during questioning.
If you cannot afford a lawyer, one will be appointed for you before any questioning if
you wish.
If you decide to answer questions now without a lawyer present, you will still have the
right to stop answering at any time. You also have the right to stop answering at any
time until you talk to a lawyer.
WAIVER OF RIGHTS
I have had read to me this statement of my rights and I understand what my rights are.
I am willing to make a statement and answer questions. I do not want a lawyer at this
time. I understand and know what I am doing. No promises or threats have been made
to me and no pressure or coercion of any kind has been used against me.
Signed ______________________________
Witness: __________________________
Witness: __________________________
Time: _____________________________
68
INVESTIGATIONS OPERATIONS MANUAL 2014
EXHIBIT 2-1
INTERROGATORIO: NOTIFICACION DE LOS DERECHOS
SUS DERECHOS
Lugar ________________
Fecha ________________
Hora _________________
Antes de hacerle pregunta alguna, Ud. debe entender lo que son sus derechos.
Ud. tiene el derecho de mantener silencio.
Culquier cosa que diga Ud. puede ser usada en su contra en un tribunal.
Ud. tiene el derecho de consultar con un abogado para que éste le aconseje antes de
que le hagamos las preguntas y también tiene derecho a la presencia del abogado
durante el interragatorio.
Si Ud. no puede pagar los gastos de un abogado, se le asignara uno antes de
iniciarse el interragotorio, si así lo desea Ud.
Si Ud. se decide a contestar las preguntas ahora sin la presencia del abogado, Ud.
tiene todavía el derecho de negarse a contestar en cualquier momento. Ud. tiene
también el derecho de interrumpir las contestaciones en cualquier momento hasta que
haya consultado con un abogado.
RENUNCIA A LOS DERECHOS
Me han leído esta declaración de mis derechos y entiendo lo que son. Estoy
despuesto a hacer una declaración y a contestar las preguntas. No quiero que esté
presente un abogado en este momento. Tengo conciencia de lo que hago. No se me
han hecho ni promesas ni amenazas y no se has ejercido presión alguna en mi
contra.
Firmado _____________________________
Testigo: __________________________
Testigo: __________________________
Hora:_____________________________
69
EXHIBIT 2-2
INVESTIGATIONS OPERATIONS MANUAL 2013
1c. NAME: OF DISTRICT DIREC TOR
1.». DISTRICT ADORES$
DEPARTMENT Of HEALTH AND HUMAN SERVICES
P"OOD AN I) OftUG A0M;INI$T?V.T10N
DETENTI ON ORDER
"· ........
l d. fMAJ LAOOflfSS
•••
u•.• .,.
10. ' "" NUMO<•
IAN
1• ·
TO:
Is.
4. TITlE Of CUSTODiAN
ut ' EN lvN " " "" ' NUMoe•
00
-
TELEPHONE NUWBER
I •· """
a.m.
7, f iRM NAME
p.m.
9, MAXIMUM
&. AOORfS$ ($111t:,. CA'y, $tift 1 liP CO<It)
DETENTI~
DAYS
Pt.nUant 10 (Cheek appJUOJe S~!fOII{~)) 0 seo:10n 3D4.(h) or ::he f ederal f ood, Drug and Co6me-:IC Act (FD&.C Act),
Gtct.TOI'II 402 Jnd 40i0 Of liM: I' tOtr.- Mill lnJptCIJOn M ,
Ste'IIOn JO.{g. or lht P"D&C A«.
0 s eo:10ns 19 and 24(b) ~the f ederal Poul!r y lnspecuon At:A, and/or 0 Sections 19 and 23(d) of tt1e F ederal Egg ProdUcts lnspeo:IOn Act,
ltlt .WCit{&) ll&ttO In biOOU 1o • 12 btiOW on 1111 rorm mull nol bt u&td. movto. Jllt rto or !Oltnptrt<l wlltl ll"' .» ny m~t~ntt d~Mtng tnt <ltlttl-llon ptfiOCI
withOUt the witt:en perm:-Wfon Of an au!h0f1zed representljye ~the secrelaly 01 the u .s . oepanmen1 of He.t.':h and Ht.rnan Soef\llees, except that a
<lt*t 1'1\Jf lit movt<l ~ proc1K4t<l und« 2 1 CFR 800.SS(hX2• pur5WOIIOStctlon 304(9)(2}(8) OHM F ~C ACI. All Jr11Cit OUOOCI <ltiJ-.tCI pul'iWnl
to Secuon J04(h) Of the FO&C M ShaD not be consumell. mewed, allf,red or tampered •aM In any mannH <I~Mfng the GeterttiOn pHioll. ooless the
<1e:enuon order 16 nr51mOIL"le<l on<lef 21 CFR t .J8 1(e~
0
0
I D. NAME Of DETAINED A!'\Tict.E(S}
11. SIZE OF DETAJNED LOT
12. DETAINED ARTICl E($ ) l.A8EU:D {be.IUOf Ml~r ClltOit LM~ti)
1>. "EASON
-
NTIOH
10. DETAJHEO N<TICL< {S) o
(N...., """'"- ZJP 0>1")
116.APPROVAL Of DETENTION ORDER
17. I'WiiE AND n TLE OF PERSON VliiOAPPROVEO THE DETENTION ORDER
0 ""'"'"
2& STORAGE Of DETAINED ARTIClES (Se!ecr appropt1are - Pe/ 21
0
0
NA-\f~
Refl'tgHa:e<l a!
·~
0
01' I"OA I!MPlOYt:~ IT)'pt orpmt}
FORM FDA 2289 (2/13)
70
0
NIA
FtoZtn
A.mblent
0
0
v...a
CF/U.J~b)(7}, !De aecamea atntfe.s Jl'l(l:Sr be s!Ofed byor.:y Ulese memoOS.}
01htr (For I'IOI)ortlf"\\tli!Wt
re.'a!ed .storageo ccncmron~; ~
Tin!! (flOA ~mpiOytf)
PREVIOUS EDITION IS OBSOlETE
SIGNAlUftf (FOA f mpiOYH)
DETENTION ORDER
1
INVESTIGATIONS OPERATIONS MANUAL 2014
EXHIBIT 2-2
1C. NAVE OF OlSTRliCT DIRECTOR
1a.. DISTRICT .ADDRESS
DEPARTMENT « HEALTHAHDHUMAN SERVICES
FOOD A.'iD DRUG AmaHISTRAllOH
DETENTION ORDER
1a. EMAe. AD-DRESS
te. FAA NUM6 ER
tt>. PHONE NUr.lEER
3. IJET9rfTIQn OI'WEi't NLW5ER
2. Hoi~ OF CUSTODIAN
TO:
DO
J.. TITlE OF CUSTODlAN
7.
15. TELEP"riOri.E NUtJ.SER
6. !li.TE ANDHOURDETAINEO
a.m.
fl.~ NA-~E
pm.
8. Al>DRESS (~
ary, Stare~ ZIPOX!e)
9 . MAXatlAI DETENTJON
DAYS
0
seo::Jon 3C!{ft) or mE F~ FOO(I, Dnl;l ana CO&I'M-'3: ACt (FO&C Att).
0 Soeo".JOn~) otme FO&CAt:J.. 0 sect::ons J.OO aM ~o~ or ere F~rall w.ea ~C;Spectron N;..
0 Soeo".JOns t9 ana 24(0)
Fa~eral PQ1':r{ JMpe-teor~ Aa.. ano.'Or 0 SectiCI'I$ t 9 ana 23(0)0: ;:ne F eceraJ Egg ProClJaSIMpeo:IOn ACt.
tne ~~(&) II&~ 111 CloCk& to 12 DeiO'M on 111& 10rm mus. t10t De u&eo.. I':'ICJiteO. al!i:r:o or tampered .an any rnann=r alJ'rng 1r1e oe;en;~Dn peftOCI
wtmorJt me wr.c=n ~on e1 <m a:atnonz..."'O! P-PfKeOti:I'F- e~ me SecrN~fJOI!' tne u.s. Departmed ot Hea:.:n ana 1-M'nan servt::es. except tnae a
ae-w::e mayoe I'I'JOI(:<I ana proc:ES$eO unaer 21 CFR 800..55(11)(2) ptlr~ ::o Section JC£{9){2)(8) or ;ne roac ACl M artiCle OlltiCJO aetaraed ~
to secuon 304(n) e~ tne FD&C AU &rial not oe c:onaJmed..I':'ICJiteO. a!!i:re<~ or wnpereo Will In any manra alJ'rng 1r1e oe-:en:10n pa1011 m 1es.s tne
a~:=nt~on O«<er te.IM moci:le<l ~ 21 CFR 1...381(C).
Ptnuant to (~ ap~ 5earon(s))
"a..
4
10. MM.E OF OETAIN:ED A.= ma.E(S)
11. SIZE OF DETAINS) lOT
12. teTAI:N.EO AATJCLE(S) lASELED (~ .WS'!t' catra; l.a.tle~
13. APPROXL~ATE VALU:: OF LOT
14. s.aJl?I_E NU.MEER
15. iEASON FOR DETENTION
15. D-ETAi..'e OA.fmCLE(S) STORED AT (Ha..m', At:tn~ ZiP COt:e}
17. MW.E ANO 1'ITLE OF PERSOHVliiOA?PROVEO THE O:TENTIOH ORDER
1 18. A:_: IPftf:NAL OF DEI:NTIQn ORDER
0 """"
19. MW.E ANO AX:IIOR:SS O f
A.~LE(S)
...OR SElLERS (Qr.e'RW
=_=vo-.r.
~. rtlii"'"A$Siil)1
O'MER
0
Vetr><t
20. HAJ.lE ,t..,S!> ADDRESS OF INITIAl. SffiPPER OR S5 U .E.i't
22. HAJJ.E OF CARRIE.' \$
23. OATE lOT SHIPPED
24.. MW.E ANOAOOFESS OF PACKING P'l_.&,.'ff
25. DATE lOT
I'L
=cav-~
26. PACKING PL.AHT USDA NU.W:R
21. EESCRIPTIOH OF SA-~PLE
28. STORAGE or DETAINED ARTJClES (Se...:a appropl'1a~ - Pet 21 CFR1.3C'3{D)(?t rr.e Cfe\afnE'a ~~ li!CISr De sr:nd DfOii•Y ~ memocts.}
NIA
O".la tfOt IXII'Het:Je"'a!We
rer.•a:-=a.s<cra~ ~; ~
QRetngera:=Oat
0
.,
0 -....
o-
NAJlf OF FDA Bf?!..OYEE (l)'pe orptrn..?
FORM FDA 2289 (2/13)
D
n nE (fDA Emp:oy:e)
SIGNAllJRE (FDA EmpJO~}
DETENTIOil ORDER
2
71
EXHIBIT 2-2
INVESTIGATIONS OPERATIONS MANUAL 2013
Section 30.4(h} of lhe Food. Drug mel Cosmeiic Ac:r ;s quoted Sec:Oon 1..liX and 1.402 of Tnfe 11. Code of ~I Regulations.
be.kM-:
are- quoted below as noOoe of oppon:t.JIWy frx appear and a
·(h) Ad~ Clealtton of Foods.
regularot}' heari1g:
( I )Detention Authority.
"Se<:iion 1.401 \ 'Vho Es entiiSecl to appear?
(A) In general. M of5c::er oc CJ,Jaifed errJ!~oyee of be Focd anciiAug Any pet'SOn who Wiii3 be entiteo-.oo:ea cWnar'l<- for die article of
~ tn.7t or6ct' the cie~. in ~noe wih me food. if seized LO:Ier section 304(a) of !he FO&C Pd may appeal a
subseaicn. of any arfic:le o1 iood th.lt is io..n:l dlrilg an inspection. deun6on o rder as specified in seaion 1.402. Proc:::edlres for
· •
•
- ·
nd - · A ~~ b - · establishing entiflement to be a danunt for p!.l"ppSES d sec6on
exarnnato'l,
ex nve~JOn u et v •JS ct ....... ~ Y _.....,, ....._,......., -:~:n.tta) d f'le FD&C Act are ......,._., tEd by ~· -plemenbl Rule C to
or cpllif.ed ~- If the officer or ~~ has reason ~
_.--~
_.
to believe that such article is ack.*eraied o r lrisbranded.
the "Federal RlAes of Civil Prooed.Jre:
( B) Seaeu<y's
An ani:le of IOod ""'1 be onlered­ Sec. 1.402 What are berrcirertJM.ts fa Sltlmittif!l an~
Cfiief'lbon Oidei, )'OU ITIJSt
)'CU
ooder Sll:lparagaph (A) ocly if lhe Secretary or an offiCial des9'1ated "(a) If you wanl iO appe
by f'le secre-131)' app-ows the Ot'Cia'. An official mlY not be so appeal in writing to the FDA. Ois:tr'ia Director. in whose disrict lhe
~ed unless the oftic:GI is !he cfrector of the d istria ~ this deaned anide of food is loca:.ed. .:c the maaing adttess. e-mail
Ac. 1"1 which the article ii'I'VCIIved is loca:ecl. or is an o.."ficiaa serior to address, « bx nul'l'llbef' identified in lhe de!Mtion order according
to the ilolcMYlg applicable timetranes:
such cfr'eaor.
(
{2) ~ of ~ An artde of food may be d63ined U'KiEf 1) Perishable food: If the detlinecl atticle is a perishable food. as
paragraph ( t ) b a reasonable period. oot to exceEd 20 days. Lriess de..~ in secton 1.377, you rtkZSt file an appeal wlhin 2 cm.sar
a !iJeaier period. not 10 exc:eed 30 days. is necessary. to enatte the days of ceceipt of the detention order.
~tary 10 insthlte an action oocfEf subsedion (a ) or section 302. (2) Nonperishable tood: f. ;be dsaiied arfde is ro1 a perishable
The Sec:tsary shall by regc.Aation proylcie for procec:Ues for in~ food. as defined in se<:lion 1.377, )'OU ll'IJS( file a no6ce of ... ir..:ent
to ~ a he.:D'lg wihin 4 calencbr days d receipt of ihe c!eteriion
such aclfcn on an exped1ed basis wl:h respea 10 perishable foods.
orciet. If lhe noti:le d inw.. is nc:c filed Wctin 4 CJiendar days. you
(3) Seamy of .,...,_ ride. An «de< unde< (1) with wJI oot be gr..vw:ed .1 he:tmg. If you have net fled a tinely no6::e of
respect to an atic:le of food may req~ ~hal such artide be labet"ed ine~t 10 request a hearYig. you may fie an appeal wi!hOIA a hearing
or marked as Osained. and shal requft th.a the article be rernowd request \ Vhe-'!her or net it inducles a req.Jes1 fur he~. )OJr appeal
to a secure fa~Sry. as a~te.. An artide smjea ro such an order ITU5l be ad within t O c:alencl¥ d ays of rec:e~ d. the c!eteriion
shall not be transferred by inf person from ihe place at whdl the orciet. (b) Y our reques1 for appeal rrus<: inc::bde a \Ef&d stat=ment
article is Cl'defed d etlined. or from the J:iace kt wfjch the article is so id~ your ownership or p-oprierary irerest in the deai'led
rEmOIIed. as the case mlY be. U'd ~by the~ « unti anfde d fOod. in acc«dance with Supplemental! RlJe C to~ Fed=lal
the expiralion d lhe O..terlion period "i1 4 · +o. under such order. Rl*s of CM f'rocedn.
whictlever occus &st- This Sltlsec6c:n may not be conslrued as
(c) The p-ocess f.or lhe ~of a d eteriion oo::ler ooder dis sedion
~ the delivay of be :ride p.nuant to me executic:n o5 a
tef'lnilaieS if FDA ins:itutes eitte a seizure aclim meier sedion
bond wtile the article is~ 10 the order. a1d section 801(b) does
not auitlorize lhe de~Nery oi the article pu'SUal'll to be execution of a 304{a) of the FD&C Act « an illunc6cn urder section 3:12 d the
FO&C Aa (2 1 U.S .C. 276) regarding lhe ar1de d bod involved n
bend while the aticle is sut;ecx to the order.
the detet'Cion order. (d) As part d lhe appeals process. you mlY
{4 ) Appeal of dEtention ordef'.
teepest an ilXwmal hearing. Y04S request for a heari'lg ITI.IS1 be in
{A) In gE'!'la'al. W Jih respect t::t an a"tde of food ordered decained under vniMQ and rrust be induded in VOJt r EQUest b an aDCIE'al soecified
paragrapn ( 1J, any person wno WOUJa oe entt:~ea 10 oe a ClaJ"''Q':l.t ;u in paragapt (a) ci m secii:ln. l;f you request an ~ he¥i"lg.
such ~ if the ar6c:le were seiEd ul"def stbsec:6:ln (.1) mlY appeal and FDA garws ycu ~st. ihe hEari1g wil be held w?ltWl 2
the oroer 10 the Secretary. WlihiJ five days aler such an appeal i$ catEnclar days air.~ lhe d~ ihe ~al is filed.·
fled. the Se<::reay, Ur pn:Mcfi1g oppcrtl.rlity ior an inform.ll hearing.
shal coriml or ~ the order if'I'\IOhled, and st.JC:b c:odirrro6on by Any Wormal hearing of a ~tion on:ler for food nust be cond.Jct=<l
the Secrewy stn1 be consideced a final agency ac6::ln for p.arposes of as a regl.bory heaMg ....oer 2 1 CFR Part 16 as ITI:ldiPed by section
section 702 oi lffie 5. lklited Slates Code. tf dtrilg such five-day period 1.403.
the Secreiary iaJs 10 proYide su:h .10 ~. « 10 coram or For more Worrnation.Jiease see 2 1 CFR Part 1. ~ K axt 2 1
tem'li\lt: such order. ihe order is deemed to be ~ted.
CFR Pan 16.
-=----
ap,.-.
a
{B) Eff&a of mftuting coun ae~:ion. The process oocier ~
(A) for lhe appeal of an ader Wider l»>'<lQraph (l ) terminates i the SecOon 30l(gJ of £he Food. Drug and CosmeOc Act is quoted
SE.-cnotary nstiules an acti.:lrn \.nder subsecfion {a ) or 'Seetim 302 below:
regarding ihe article ol food hvohed.•
1 gX1) tf ci.rilg an inspection COf'lliJc:led IXIder Sec6on 704 of a facility
or a velicie. a deYX:e wtictl the cdicer or errplofee makirg the
Please see 21 CFR 1.402 (copied hefe) for the requftments f« inspection has reason 10 beieve is achJ3ated or misbranded is b.lnd
s i.Dnitti'lg an appeal tf you decide to appeal the detedion arcler. in such facility a wBc:le. such ci'ficer or EfllliOOJee may on:iEr the
you may also request a hearing as part ol the appNI by fiing a device cletli'led (n aco::Acbuoe wih regU:Cions ~SO"bed bv the
timely notice of inted to request a hearing and then noting yo!X Sec::retary) b' a reasonable period Mich mlY rot exceed l!JieOty days
request ftt a hearing as part of YOIX appeal Pursuant to 21 CFR unless he Sec:reory~ f1a a peRxl aide-~ !J'Nier tha'l:
1&.26, a request for a heaOOg rMf be denied. in whole a in part if twenry days is requY-ed to ins:ftute an action \ftfler SUbsection {a ) «
the Presidng Officer determines that no genu ine and substantial Sec:ii:ln 302. in 1111hich case he may au1hcrize a del:erllion period of (10(
issue of fact Ms been rarsed by the l'l'l.itterial submitted. A hearing to excEEd "'"~'days. RegLt;tXns of the Seaa.vy pescri>ed .me<
will not be granted on issues of poicy or law. I you ~t a this paragaph sh.lll requle that befcre a devi:le rray be ordered
hearing as part of your appeal you should SltMnit with your appNI derar.ed lRfer tns paragaph t.e Secr;;:ay or an Cliiic:a- « employee
and request for a heaing the materials. dab.. and information that desq.a:=o by ~ Secretary ~ such ordef". A detenion crder
yoo beliew- shows there is a genuine and sU>stwrtial issue of fact unda' tis parqaph nuy ~i'e t"le bbelng or marking d. a device
regarcing the popriety of the ~ntion and any other information dl.l'q;; the period of is detention i::lr lhe pzpose d. i~ the
you WOIAd like the presiding offic:ef to considef" when decidng device as detaWled. My person who 'CIUid be ritled 10 claim a
yout appeal and request for a hearing. If your appNI is denied. device if l were seized ...ndef'- Subsection (a) may aweat 10 the
writen notice of a determination of s urrmary Ju<%,wnent will be Secret.lry a detention ol suc:fl device e.nder tlis paragaph. \VIihil five
pf0¥ide.d. explaining the reasons for denial • you do not request a days d an appeal d a daentioo 6 S=<l w1h the Seaetary. the
heaR'Ig as pan of yo11 appeal you shoukl submit wih yo!X Secretary sha1 after a:fon:f'i1g q:patlriy for an ~ heari-g by
appeal a1 of the materials. data and information that you would on:la" ~ ihedetrion «revoke it
111ee cne f"res ltwng omce to consaaer wnen GeCICing yout appeal.
FORM FDA 2289 (2113)
72
PREVIOUS EDIT10N IS OBSOLETE
as-
INVESTIGATIONS OPERATIONS MANUAL 2014
12XAl E>oepl
by-
(B). • ...qect
order issued under paragr3Pl: (1) shall 001 be mowed
by any pason trom the place a1 whic:b it is ordered deaned una •
1i) released by lhe Secretary. or
1i) the a;Wation of the detention period Wocilble 10 such order.
whichewr occurs &st.
\B) A~ sul:ject to a detention order IXlder pa~cq.,.P o (1) may
bemowd;o a d~
EXHIBIT 2-2
()n;g. and Cosme6c Pd. wilh respea 10 any ~s.. P3J'! the~
mal. or meal food podJct of cartJe, shteep, swne. go<n. a e<fJII'IeS
tta; is ou;:si::ie any pem]ses at wlich ilspecticn is being mailtaned
tnder !his /Ia. and for such P1.fP0SeS the firs.i reference to n
Sec:Mary n Secticn 402 shall be deEmed to refer 10 the Secm.3ry oi
Heath and
Services. (2t
ffl9r
lbnan
u.s.c.
Seet.ions 19 and 2l{b) o f me Pouluy Prodi.ICf:$ hspecOon Act is
1i) in aeeon:l3n~ li'!h r~ons pr..&eriMd bv me. SE<:r'd:uy . .zcf quorodbfiow:
1i) if not in final form for ~ a f'le discn;fon oi lhe tnlnufal::uer '"Sec. 19. ~ ~e·.rer any pcdry proQx:l. 01 any p-oduc:t exernpo;od
d. the devi:le for tJe p.rpose ci w 1c:*£ og the wert req.nd to p.c il in ian the deklition rA a poultry proci.lct. orany dead. c¥ng, cisabled, «
such !am'
ciseased pcUrry is i:uld by an .3l.lhcrized ~ of ~
~ lPl"' any pernises llhere it is held fot p;rposes of. 01 dLIYg
SecOOn a:J0.55(gXf}(2} of rme 21. Code ofFederal RegutalircJn:&.. is « ~.er dis:!hltion n. commerce or od':erwlse st.t:;ea to ltfi lvJ. ard
quoted be4ow as oorice of opponuniy for i~~ppHI and a regulatory thete is reason to believe bat any such .:ri:::Se is .31i:t-'-dated «
,_~
nistranded and is capable d use as funan bxl. 01 lha l has oot
tleen i •spea..._'"<f.. in W:la!ion of a prooMions oi hs Pd. ad any od1et
1g)Appeal oi 3 tEen6on Ofder.
Federal blr rs the tMs of at'l'f Sta:= or Teriay. or the District ci
(1) A perscr~..W.O would be erfted 10 dain the deo.ri~. i ~ may
Cotntlia. 01 thai it has been ex is nteroec~ to be. cfsri:luted n viobi:Ut
appeal a deten6cn order. Ant appe311 shal be ~ m wdilg 10
roA OisN Oirec::u in ....nose district ihe devic::es <n locale<! wiitin 5 d any 9JCh pcw"isions. It m.7f be (Se.tined by Sl.do re~ fa' a
worting cbys oi rece"pt rA a detenlicft order. I me a;::peal FldOOes 3 perO:I not 10 exceed wwenty cbjs.. ~ actic:n lrlder 5Edion 20 d
ttis Ad. cr rof5catic:n ot any ~. State. 01 other gowemmerU
req.Jest b an irli:xmll he¥ng. as defned n Sec6:n 201(y) d lhe
Ad. ~ appeltn 'Shall request ei!"a :hat a hearilg be hekl wifWI 5 aAlorities havi'og jl.risdiclion Olle' such a1icle or pcl.lltry. ard sh.lO oot
worting cbys a:ter the appall is filed 01 th.ll ihe hearing be held' a1 3 be rn::J\Ied by any perscr~, fran be ~ a whi:h t 5 localed ~ so
~. LJ"d rei'e3Soecl by suc:fl represeaat:ve. AI ci6cQI marks rroy
a~ da;a which shall not be later ih3n 20 catEncbr days after receipt
be requred by such ~ to be rer'l'iO'.I'ed tom su::h art"de «
of thedesfuoon:ier.
pootry betcre it is ~ t.dess it appears to be sX.sfac:ticn d the
(2) The appellant d 3 de-:ention ~ srol ~ the ~ershP or ~ dut lhe :ride or pcU;y is Eigible to reain such traits.·
propri:-t3ry nterest the appelant has 10 the c:iaaned dwices. I the
cietaned deYices a-e located a1 a pbce other ih.ln
SEc. 24
owned a
~ by
ihe
~
an estabistment
the
appelant_ sha'l ~ ·{b) ~ cieGai'a aJtoity o::ub'ed
by Seeton 19 d ttis lvJ st\711
~ ~.that. d'1e :welar« wol.i:l have ieQi&nxe a.ch.:lrity 3f.PY 10 ;ny a.rihorizecl ~ve d d'le Secretary of Hs.llth am:
10 cla'm fte deYJOeS if seia>d.
f-b:n3n 5aVces fer p.rposes ci the Ef'lixc::etnat d the Federal Food.
Any informal hearWlg on an appeal d a deterrfoo order b dewices Cruel and Cc:snetic N:l. w:th respec:t '10 any poul;y ClrC3SS.. 01 pan «
shal be o:n::lucteod as a regAatory heari'lg U1der 2 1 CFR Part 16. wiih procbct ther-=-0.1. ~ is outside any official estal:lfsh:ne.nt. ax! for su::ta
certain exceptions desaibed W'l 2 1 CFR § B00.55(g)(3).
~ b first retaence 10 the Seaelary in Section 19 sh.lll be
deemed to tSer to the Secre-t¥y of Ham al"'d 1-k.man SeMc:es.•
Secrions 11)2 and l09(b) of the federai MH.r tnspecrion Ac:r is
quoted below:
Seet.ions 19 and 23{d) o f £be Egg PtodUCF$ lnspe<:Oon Acr i:&
-sec. 402. \~ arrye3C'aSs, pan of a <3'CaSS.. mat01tne3Ciood quored below,
p-ocluct d ca:ile. sheep, ~ go.:m.. horses.. .l"!'des. rx other ePnes -sec. 19. Whenever actf eg;s oc egg IJ'O(Ucts sd:jec:( '10 lhe Ad. are
a arry p1Xiuct eX9'1'1J(ed ian lhe cieirition d a meat b:ld proclu:::t. or fO.nj by ant aulhc:Jriuod ~'IE of the SecrE'try ~ ant
any dead. ctyng. cisabled.. a diseased CX!Se. sheep. 5Wine. goot. or premises aod there is reascn 10 bEfefe that lhey are rs haw beEn
equine is b.Jnd by any .llJihcrized repcesenb..._"'.e of lhe Sec:rebry lPlf'l jXOCessed. brougtl. sold, possessed, used, II 4l$p() ted. 01 ofcaed
any penises whele il is ted for prposes cii. or cbilg « af"~ « received b sale a tra tspa: tafun n Wllaticn d lhis hi. or Ita
c:istri:lufc:n in. w:..aEtce rs o:nerwise subject 10 Tide I a II of ttis Ad. they are in ant ote w:xy m violation of this h:l.. or whenever ant
an::1 !here is reasoo to beli:ve lh<K. at'l'f such article is adllter<nd or resric1ed e9iJS ~ d use as hi.WI'a'l food ~ fou...:t by such a
misbranded and is e<rpable d. use as hiXMl bxl, or f\3l il: has no! ~t:at-E n the possession of ant perscn not aub::lrized 10
beEn in:spected, W'l vi:llatic:l'l ci lhe pttNisions d Tide I d this Aa 01 of acquire su::fl eggs LrXief lhe n:gul36ons ci the Secretary. sucto articles
any oiher Federal law or lhe laws of any State oc Temtcry 01 the Ois:rict rn::ty be decained by such represenb.."'ve fot 3 rasonal* period bu
c:J. ColunDB. or tut such article a arWn3l has been « is Wended to not kl exce-ed twenty days.. pen:frlg .JC6Jn lrlder Section 20 d this-~
be. dislritu.-=d .. viol2tOn oi any such ~&ons. it may be detained by 01 outifwtiolod any Federal SUre. oc of)E{ ~f'll31 authoriies
such representa&e fot a period not 10 exceed U~enty days.. pending nMlg jl.risdi:::tion CJ~Jer such <ricles and sh3ll oot be ITIOiiled by ant
action ...mer SectiJn 403 d flis Ac. 01 notific.3fcn of ant Federal. Str.e. person fron f'e place a; Mi::hlhey are loc:3r.ed vob:n so dEtained \dill
or othEr g:JWmmercal auth::riies h.-wi1g jurisdic:6:ln Cl'tlf5 such article or re£ased by" such ~ All official m.ri.s may be recp.i'ed by
anin.ll. a'x:l srol 1"101 be tOCIW"ed by any pet'SCI'I, fiom.. oc wpuafoo st.J:b ~ 10 be rem:::wed from such <rides beebe they are
from the J:bc::e .:cllbc:to it is locXed ¥ft!n so cieoi'led. 11161 release by re£ased Lriess it ~rs to lhe satisiac::5on oi d:E Sec:tet3ry that lhe
such repcesentlfwe. .M ciic:ial marts may be rec:Pred by such arfdes are elgble to recain such ma1i::s.•
~ to be rei'I'W:JIIIEd fn::m such alfde or arWnal befute il is
released l.dess i: ~ars 10 the ~On d the Secretary thai ;:ne
-sec. 23(d). The da3i'ler aLihority c::cwierred on ~ives d
afdea anirL3I is eligi:lle ll) raan su::h mJrlts._ (21 u.s.c. 672.)
... ~of Agicuhlnl)\'- 19 ol
any authorized repesentative ci lhe Seaetary d Hea"!h and~
Sec. 409.
5Ervioes b' the p..rposes d paragf<4il {d ) of Section 5 d this At.t.
(b) The
aulhomy CX>nfe<red l)\' Seo6cn 402 ol 1tUs Aa. shol ¥do respea to any eggs or egg proch..cts t:h:i< are outside any plant
apply 10 any aulhcriz.ed repcesentaive of the ~ of HealD and ~egg-:
Hurn..11"1 Services b' purposes d !he a •Xx ca 1:ert of the Federal. Food.
tis""'- -.,
-'*<
FORM FDA 2289 (2/13)
PREVIOUS EDITION IS OBSOt.ETE
73
EXHIBIT 2-2
INVESTIGATIONS OPERATIONS MANUAL 2013
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
U.S. DETAINED
The Lot of goods to which this tag is affixed is
DETAINED BY THE UNITED STATES GOVERNMENT
In accordance w~h the provisions of Section 304(h) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act); Section 304(g) of the FD&C Act;
Sections 402 and 409(b) of the Federal Meat Inspection Act; Sections 19
and 24(b) of the Poultry Products Inspection Act; or Sections 19 and 23(d)
of the Egg Products Inspection Act, the merchandise listed below is hereby
detained for the period indicated. The merchandise must not be used,
moved, altered or tampered with in any manner during that period without
the written permission of an authorized representative of the Secretary of
the U.S. Department of Health and Human Services, except that a device
may be moved and processed under 21 CFR 800.55(h)(2) pursuant to
section 304(g)(2)(B) of the FD&C Act. An article of food detained pursuant
to Section 304(h) of the FD&C Act shall not be consumed, moved, aHered
or tampered with in any manner during the detention period, unless the
detention order is first modified under 21 CFR 1.381 (c).
WARNING: Removal, alteration or mutilation of this Tag or Violation of
any of the above conditions is punishable by fine or imprisonment or both.
SEE REVERSE OF THIS TAG FOR
DESCRIPTION OF DETAINED MERCHANDISE
DETENTION DATE &
HOUR
DETENTION NOTICE NO.
U.S. DETAINED
a.m.
p.m.
ON
MAXIMUM DETENTION
NAME OF DETAINED ARTICLE
DAYS
NAME FDA EMPLOYEE ISSUING DETENTION NOTICE (Print or type)
DETAINED ARTICLE LABELED
SIGNATURE FDA EMPLOYEE ISSUING DETENTION NOTICE
TITLE FDA EMPLOYEE ISSUING DETENTION NOTICE
NAME FDA EMPLOYEE AFFIXING TAG (II different from is511ing employee)
SIGNATURE FDA EMPLOYEE AFFIXING TAG
TITLE FDA EMPLOYEE AFFIXING TAG
FORM FDA 2290 (12/13) Prev. Ed. May NOT Be Used
DETENTION TAG
SIZE OF DETAINED LOT
SEE REVERSE
FORM FDA 2290 (12113)
74
BF
INVESTIGATIONS OPERATIONS MANUAL 2014
EXHIBIT 2-4
1a. DISTRICT ADDRESS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
850 Third Ave.
Brooklyn, NY 11232
FOOD AND DRUG ADMINISTRATION
DETENTION TERMINATION NOTICE
Thomas Gardine
1b. PHONE NUMBER
718-340-7000
2. NAME OF CUSTODIAN
TO:
1c. NAME OF DISTRICT DIRECTOR
3. DETENTION NOTICE NUMBER
Mr. William Jantz
DN 60006
4. TITLE OF CUSTODIAN
5. DATE AND HOUR DETAINED
Warehouse Manager, Division II
10:45
12-29-05
6. FIRM NAME
a.m.
p.m
7. DATE AND HOUR DETNTION TERMINATED
Amoure Cold Storage Co., Inc.
8:35
1-6-06
a.m.
p.m
8. ADDRESS (Street, City, and State)
9. ZIP CODE
245 Dockage St.
Buffalo, NY
14206
The merchandise listed below which, pursuant to Sections 402 and 409(b) of the Federal Meat Inspection Act; Sections 19 and 24(b) of
the Poultry Products Inspection Act; Sections 19 and 23(d) of the Egg Products Inspection Act; or Section 304(g) of the Federal Food,
Drug, and Cosmetic Act, was detained on the above date and bears the above detention number, is hereby released and the detention is
terminated.
10. NAME OF DETAINED ARTICLE
11. SIZE OF DETAINED LOT
Beefy Brand Beef Pot Pie with Mushrooms
1600cs/24 – 1 lb. 2 oz tins
12. DETAINED ARTICLE LABELED (Include Master Carton Label)
Tins labeled in part with paper labels: “Beefy Brand Pot Pie***ingredients: Selected beef, choice green peas,
carrots, selected Idaho potatoes, Mushrooms***Gravy composed of: Water, beef stock, and flour***Net Wt.
1 lb. 2 oz.***Packed by Burly Products Co.***General Offices Kansas City, MO EST 223” Tins in cases
labeled in part: “***24/ 1 lb 2 oz tins Beefy Pot Pies***EST 223***”
NAME OF FDA EMPLOYEE (Type or Print)
SIGNATURE (FDA Employee)
TITLE (FDA Employee)
Sylvia A. Rogers
Sylvia A. Rogers
Investigator
FORM FDA 2291 (12/05)
PREVIOUS EDITION MAY NOT BE USED
DETENTION TERMINATION NOTICE
1
75
EXHIBIT 2-4
INVESTIGATIONS OPERATIONS MANUAL 2013
1a. DISTRICT ADDRESS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
850 Third Ave.
Brooklyn, NY 11232
FOOD AND DRUG ADMINISTRATION
Thomas Gardine
1b. PHONE NUMBER
DETENTION TERMINATION NOTICE
718-340-7000
2. NAME OF CUSTODIAN
TO:
1c. NAME OF DISTRICT DIRECTOR
3. DETENTION NOTICE NUMBER
Mr. William Jantz
DN 60006
4. TITLE OF CUSTODIAN
5. DATE AND HOUR DETAINED
Warehouse Manager, Division II
10:45
a.m.
12-29-05
p.m
6. FIRM NAME
7. DATE AND HOUR DETNTION TERMINATED
Amoure Cold Storage Co., Inc.
8:35
a.m.
1-6-05
p.m
8. ADDRESS (Street, City, and State)
9. ZIP CODE
245 Dockage St.
Buffalo, NY
14206
The merchandise listed below which, pursuant to Sections 402 and 409(b) of the Federal Meat Inspection Act; Sections 19 and 24(b)
of the Poultry Products Inspection Act; Sections 19 and 23(d) of the Egg Products Inspection Act; or Section 304(g) of the Federal
Food, Drug, and Cosmetic Act, was detained on the above date and bears the above detention number, is hereby released and the
detention is terminated.
10. NAME OF DETAINED ARTICLE
11. SIZE OF DETAINED LOT
Beefy Brand Beef Pot Pie with Mushrooms
1600cs/24 – 1 lb. 2 oz tins
12. DETAINED ARTICLE LABELED (Include Master Carton Label)
Tins labeled in part with paper labels: “Beefy Brand Pot Pie***ingredients: Selected beef, choice green
peas, carrots, selected Idaho potatoes, Mushrooms***Gravy composed of: Water, beef stock, and
flour***Net Wt. 1 lb. 2 oz.***Packed by Burly Products Co.***General Offices Kansas City, MO EST
223” Tins in cases labeled in part: “***24/ 1 lb 2 oz tins Beefy Pot Pies***EST 223***”
REMARKS
The Culmore County Health department assumed jurisdiction of the product at 8:35 AM on 1-6-06 when it
was released from US detention. The entire 1600 case lot was hauled on 1-6-06 by the ACE Trucking Co.,
2993 Longway Place, Buffalo, NY, from Amoure Cold Storage Co., Warehouse #3B, 321 Dockage St.,
Buffalo, NY, to the county landfill at Port Road and Culmore County Road #8 where the lot was dumped,
crushed by bulldozers, buried in a ditch, and covered with approximately five feet of earth.
The entire operation was supervised by Culmore County Health Department Inspectors Robert J. Sandi and
Henry D. Larky and FDA Investigator Sylvia A. Rogers.
FDA supervision time and expenses:
Inspectional time – 6 hours
Mileage – 22 miles in US Gov't car G11-396
Sylvia A. Rogers
Sylvia A. Rogers
Investigator
NAME OF FDA EMPLOYEE (Type or Print)
SIGNATURE (FDA Employee)
TITLE (FDA Employee)
Sylvia A. Rogers
Sylvia A. Rogers
Investigator
FORM FDA 2291 (12/05)
PREVIOUS EDITION MAY NOT BE USED
DETENTION TERMINATION NOTICE
2
76