case study: fda recall and u.s. marshal’s seizure

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www.StrongPharma.com 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 [email protected] PHARMACEUTICAL SERVICES TM problem A 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. SolUTIon bcaus 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- tyuicia 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 and U.S. Marshal’s Seizure continued Copyright © 2009 Stericycl e, Inc. All rights reserved.

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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

[email protected]

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.