Case Study: FDA Recall and U.S. Marshal’s Seizure
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Transcript of Case Study: FDA Recall and U.S. Marshal’s Seizure
8/8/2019 Case Study: FDA Recall and U.S. Marshal’s Seizure
http://slidepdf.com/reader/full/case-study-fda-recall-and-us-marshals-seizure 1/2
w w w . S t r o n g P h a r m a . c o m
Case Studies
Who We Are
Strong Pharmaceutical Services, a division
o Strong Environmental, Inc. (a Stericycle
company), is the leading provider o destruction
services to the pharmaceutical industry. Our
experienced proessionals manage and ensure
the appropriate witnessed destruction o
DEA controlled substances, as well as proper
disposition o RCRA hazardous and non-
hazardous fnished goods and manuacturing
wastes. When we take control o waste
materials at your shipping dock, they become
our ull responsibility.
Strong Pharmaceutical Services: Secure
Pharmaceutical Destruction Solutions
6264 Crooked Creek Road
Norcross, GA 30092
770.409.1500 800.778.7664
PHARMACEUTICAL SERVICESTM
problemA haacutica aufactu was
fcd t cs its ds du t a
FDA Cass II ca. Th U.S. mashas
Svic th sizd th ivty. Tw
dz tai ads f du-stackd
ats aiig i stag quid
dstucti.
SolUTIonbcaus th cay’s ds w
csd f v tw yas i t this
dissa jct, a tchica ctact
was t avaia t asw qustis
gadig ivty ad uad
ducts. Dtiatis had t
ad qustia ivty whi
th dissa ad dissiti fft was
i css.
S f th duct ctaid tac
auts f epA-guatd tas
ad additia chicas. oc ths
atias w dcad ‘wast,’epA guatis gvd dissa
thdgy.
CAreFUl ConSIDerATIon
oc a haacutica atias
w chaactizd, Stg tchicias
cafuy sggatd th. Du t
th th difft titis guatig
dissiti (epA, DoT, FDA) this
cssitatd th us f difft tys
f dstucti thds, icudig
scu adfis ad iciati
faciitis.
Th uk f th atia was dstyd
via ctd ad witssd
dstucti ad susqut scu
adfi. Th aid f th wast
(atias high i rCrA tas
ad epA istd wasts) was as
aiaty dstyd.
Stg acs safty fist. Iciats
w sctd i csidati f
oSHA’s stict guidis f dstucti
f wds, s that ys w
tctd f ihaig ctts
duig dstucti. A dict fd uit
was th chic; us f a “it-
ty” uicia iciat wud
hav xsd ys t ssi
wd ihaati.
SUCCeSSFUl ConClUSIon
by atig with SeI, th U.S.
mashas Svic achivd uti-
agcy ciac whi aitaiig
cst-ffctivss ad ssiv
svic.
FDA Recall andU.S. Marshal’s Seizure
continued
Copyright © 2009 Stericycle, Inc. All rights reserved.
8/8/2019 Case Study: FDA Recall and U.S. Marshal’s Seizure
http://slidepdf.com/reader/full/case-study-fda-recall-and-us-marshals-seizure 2/2
w w w . S t r o n g P h a r m a . c o m
Case Studies
Copyright © 2009 Stericycle, Inc. All rights reserved.
Not all pharmaceutical waste is EPA non-hazardous.
In this case vials, some marked only with a trade
name, were carefully evaluated and properly
classified as an EPA regulated waste due to
Chromium and Epinephrine content.
US Marshals kept product under supervised lock and
key for two years.
This project required the inspection of almost
ONE MILLION containers.