070811 483 redacted applied_Redacted-508.pdf

7/28/2019 070811 483 redacted applied_Redacted-508.pdf

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EMPI.0Yff(SI $1CNAlUI\f ~ ' " ~ " " ' : >Eric M. Mue lle r , I nves t igatorSEE REVERSE Joseph R. Lambert , s t i g a t o ~ ~ 07/0 8/ 2011OF THIS PAGEOIIM t OA (0'1101) ,l eVIOU1 fD ITIUN OIJSOlETr INSPF.CTIONAL OllSF: RVA'r tONS P,\(j I01' H A G I J S

DEPARTMENT OF HEALTil HUMAN SF.RVICES FOOD AND DRl:G ADMtNtSTRA'rtON OISTRICT ADilftfSS "'-0 """he NtWDtll11630 'II. 80th StreetLenexa, KS 66214(913) 752-2100 Fax: (91J) 752-2111Industry I nformation: www.fda.gov/oc/industry

OAT(IS)Of .,SECTlOH06/13/2011 - 07/08/20 11 "rE I Iiut.oii(R1911445

NAME AJO l l lU:Of 10 WHON IIEPORT l>sut.OTO : Terence J . Walsh, Site Leader"""'Novartis Consumer Health STAU 'AllORUI1040 1 Hwy 6

CITY, l P ~ I J V N T " 'Lincoln, NE 68517 - 9626

T Y P E ~ INSPECT< I>Drug Manufacturer

This document lists observations made by the FDA rcprescntattve(s) during the mspcction of your f:tclluy . They arc inspcctionalobse rva tions, :tnd do no t represent a final Agency dctermin:llio n regarding your compliance. Iryou have an objection regarding anobservatiOn, or have tmplemcntcd, or plan to tmplemcnt , corrective : ~ c t i o n in r c ~ p o n s c to an observatio n, you may discuss the objection orIICIIOn with the FDA representativc(s) during the inspection or submit this information to r DA at the address above. If you have anyqucsttons, please eontuct flDA at the phone number and address above.

DUR IN G AN INSPECT ION OF YOU R FIRM WE OBSERVED :

OBSERVATION 1The responstbtlities and procedures applicable to the quality control unit are not fully followed.Specifically,Your Quality Uni t has fa iled in the respons ibility and authority to monitor Quality Systems designed toassure the quality of drug products manufactured and packaged at you r firm . This failure is evide nced inthe Observations below (2-l3), as well as continued NDA Field Alerts and recalls for similar problemsover the las t several years.

OBSERVATION 2Written records arc not a lways made of investigations into unexplained discrepancies and the failure of a batch or any of itscomponents to meet specifications.Specifically,You have failed to open deviation investigations into numerous "critical" consumer complaints offoreign products found inside the drug products manufactured at your firm.Specifically,In the year 20 I0, you had 26 complaints where solid dosage form products (with confirmed mix -upcomp laints ofNovartis Consumer Health "NCH"-Lincoln manufactured product) were re turned to yo ur


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DP,\ RTMENT OF HEALTH AND HUM AN SERVICESFOOD AND DRUG ADMINISTRATIONOlli1R1CT A O O f l f U h O ~ N\NOER11630 w. 80th S tree tLenexa , KS 6621 4( 913 1 752-2 100 Fax: (913 ) 752-2 111Indus try I n f ormat ion: www.fda.gov /oc / industryNAME" " " ll U Of HlMDUAL TOWitOM REPORT ISSIIEOTO : Ter e nce J . Wa l sh , S t te Leade r

$1RUT AOOM$ll- 10401 Hwy 6ovar t i s Consume r Hea l thOAT[(SIOT..SPlCTiOfl06 / 13 / 2011 - 07 / 08 / 2011 *1911 44 5

TYPE E$1AIU$i (4) con sec utive ly.These are just two examples of numerous instances in whicb your firm's deviation investigationsdo not extend to other lots/batches of product potentially af fected by the problem.

THIS IS A REPEAT DEFICIENCY FROM THE PREVIOUS INSPECTION AT YOUR SITE,DATED 4/5-16/ 10.

OBSERVATION 4An 1'\0A-field A len Report was not submilted within three working days of rece ipt o f in fo rmation conce rn ing an inc1dentthai caused o dn1 g product o r its labeling to be mislaken fo r ano1hcr nn ic k.Specifically,You have failed to file NDA Field Alerts within 3 days of a problem being identified .You have received numerous consumer complaints which were not submitted to the FDA asrequired by your firm's procedures:


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For example:A) Since Oc tober of20 I0 (a period in time where second person review of consumer complaints ceasedat your finn), there have been 21 consumer complai nts (for NDA produ cts) that procedurally shouldhave been reported as 3 day Field Alerts. A review of tw o individual Technical Complaint InvestigationReports fo r two of these NDA mix -up complaints (case 10642 591 and case I0675854) revealed yourinvestigation and conclusion Uus ti fication) for not subm itting 3 day Fie ld Alerts was inadequa te. Also,these two reports are indicative of a pattern of problem at your firm.It shoul d be noted that th is number was on ly verified beginning from Oc tober 2010, but is indicative of apro bl em fo r all consumer complaints received by your fim1 for mixed solid dosage fonn produ cts on themarket.

B) You have failed to file a 3 day Field Ale rt as required by your procedure, fo r complaint 10650826regarding a mix-up of Excedrin Migraine Caplets , received on 1/26/ ll. The complaint sample wasreceived by your finn on 2/14111 and confinned on 211611 I. However, your initial 3 day Field Alertwas not submitted un til 2/22/1 1.It shou ld also be noted the conclusions drawn into the inves tiga tion of this mix-up did not appear to besuppo rted by evidence gathered during the investiga tion. (See Observation 8-C)

DEPARTMENT OF II EALTH ANO II UMAN SE itv iCES FOOD AND ORIJG A0.'-11NISTRATI ON l!.lf1SIOFlloiSPEC1 ~OiSffOICf AOCAUSNCI't


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o : PARTM[NTOF IlEALT il HUMAN SERVIC51'000 AND ORUO AD\11:-.II


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I I05TR ICT R ~ S S ANO PHONE N V M ~11 630 w. 80th St ree tLe ne xa . KS 66214(9 13) 752 2100 Fax: (913} 752 2111I ndustry I nformation: www . fda .g ov / oc/ indust ryNAME ANC TITlE OF INONIUAL TO WHOM Rtt"VP>tMt:NI l ~ l ' l : < . ;

Drug Manufacturer

UCPARTMtNT Of 11Al.TH AND HUMAN SERVI Cf.Sf OO DAND DRUG AO!Io!INISTRATIONDA.TEIS)OF INSPECTION

EMPI.O'tt:E(SISICNATIJRL OA


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OF IlEALTH ,\ NO HUMAN S ERVICESFOOD AND ORUO AOMINISTRA riON,...., ....., . . , . , . . . ~ ..., . . . , . . .HI )..... .

06/1 3 / 2 0 1 1 . 0 7/ 08 / 2011 *Le nexa , KS 66 214(913 } 752 21 00 Fax : (913 } 752 21 11Indus t ry I n forma t ion : www.fda .gov / oc / indus t ry

11630 W. 8 0 t h S t r ee t

Mlolf lftJ ITU or ' " " "10JAI. JU WHOM IW'ORT ISSU0,__O : Te r ence J . Wa l s h , S i te Leader10 401 Hwy 6ova r t i s consume r Hea l thTYP t S1- HT ...sl'tCt0rrv sTAn .v CXXlE couoronDr u g Manufac tu re rinc o l n , NE 685 17 - 96 26

(lo'PI.0 Yff l5) S"" 'ATIJRO k : / ~ 08 r ic M. Mu e l l e r , I nv e s t iga t o rSEE REVERSE Jo s ep h R. Lambe r t , I n v s t i g t o r ~ [& 07/08 / 20 11OF THIS PAGE~ v t O l l ED ITlOH OBSOLP.TE INS PEC f iONAL O BSF.KV1\T IONS MG F.1 OF IJ PAG I::>

Since 2009, you have received approximately 57 return ed customer complaint, mix -up samplescontaining on ly NC H-Linco ln produced product.Despi te the continued evidence of solid dosage form mix-ups over these years, you have not determineda root cause of tablet/capsule/geltabs mix-ups .As an example of the abo ve,A) You have fa iled to justify the roo t cause for a recent mix-up complaint ofEx cedrin Migraine Tablets,Lot# 10087498, mi xed wi th Excedrin Migraine caplets.The direc t cause was ident ified as "Occurred ou ts ide Novartis Lincoln Co ntrol", however, the re is noevidence to support you r root cause. This is just one ex ample (showing a pattern) in which the roo tcause of the mix-up was determined to occur outside Novartis Lincoln control with outdocumented justification.Las tly,Your co nclusion re ads in part, "**based on this investigation, it is no t possible that the products weremixed within Nov artis control."However, a review of th e investigation into this problem revealed Excedrin Mi graine Caplets werepackaged on the sam e line Ill> fou r orders prior to Exccdrin Migraine Tablets, Lot: 10087498, an dimm ediately a ller.B) You have fa iled to j ustify the root cause de termination for a recent mix -up compl aint ofExcedrinMig rain e Gel Tabs, Lo t # I0072553, mixed with Excedrin TH Ex press Gels .You ha ve concluded, "The only poss ible way tha t the Exccdrin TH Express ge l caplets to have ended upinside the Ex cedrin Migraine GelTabs was for it to hap pen after the customer had opened the bottle.''Howev er, there is no documented evidence to suppo rt this roo t cause.T HI S OBSERVATIO N DEMO NSTRATES A PAT IER!l OF PRO BLEMS AT YO UR FIRM.


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OPAIHMENTOf HEALTH AND HUMAN SERVIC F.S FOOO ANDDRUG ADMIJI:ISTRATION DATE(Sl OF INSPECTIOHO5TIUCT COI'us ..o oH6iieN\J"u" 06/13/2011 - 07/08/2011 *11630 W. 80th Street

Lenexa, KS 66214 1911445(913) 75 2 - 21 00 Fax: (913) 752 -2111Industry Information: www.fda.gov/oc/ industry- ANO TITU! 01' INOIV-DU..\L TO WHO>ol E l ' O f < T ISSUEDTO: Terence J . Wa l sh , Si te Leader

STREeT ACORtSS-rillll.lNAUE 10401 Hwy 6ovar t i s Consumer Health l VPE t s AIII.ISHMEHT ~ C T 0Clr\';STATE, :.P QOOt: ,GOU>rTRYDrug Manufacture rLincoln, NE 68517-9626

E...,LOYEEtS) S


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O F . P O f Hf.ALTH A. l l) IIUMA I'I Sf; KVICF.SfOOD AND DRUG ADMINISTRATION""''""'t-$SAHO--Mi l

11630 w. 80th S t r ee tLenexa , KS 66214(9 13 ) 752-2100 Fax: (913) 752-2111Industry Info rmat io n: www.fda .gov/oc/ indust ryHA.IoOI! No() flU< () I ' .. .,.,.......... 10 WMI,l.. M < f ' U < l i " : W ~ D TO: Terence J . Wa l sh , S i te LeaderfiRM I"""Novart i s Consumer Health 10401 Hwy 6

DAlllll01' INSPtCliON06/13/2011 - 07/08 / 2011 *f(II>IJMM"191144 5

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( ) J : P R T M f : OF IlEALTil AND HUMAN SE RVIO: SFOOD AND ORI.!G A D M I N I ~ i ! I A rtON -OATE(Slll' lhSl'ECTIOND


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l MI>t.OYE.ftSI SIGNA VAE D.\lf I S S I JEric M Mue l l er , I nvest igator t;V_EE REVERSE Jos eph R. Lambert, I nvest igator q ;- 07/08/2011OF THIS PAGE

I'll!!\.OllS EDit'lONOlllOILTI' INSPECTI ONAL ODSEitv i\TIONS Pi\GI! II OF 1.1 M


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(IM',Q"J1!C..:>)" " " " " IUJOf OA E t:>SUEOEr i c M. Mu e lle r , Inves t i ga to rSEE REVERSE Jos e ph R. Lambe r t , v e s t g a t o ~ a ~ O BOF THIS PAGE

..IIPV.Otli f!UITIIJNOI\SO I.tl'r E INSPECT IONAL ODSERVATIONS PAGE OF IJ PAGJ.S

- llJ:PARTMF.NT OF HF.ALTII ANO II UMAN O1000 fiNO DR UIJ ADMINISTRATION

O l t ~ I O C T o .fSS AHO-NYMI!ER11 63 0 W. 80th St r e e tLenexa, KS 6621 4(91 3) 752 - 2100 Fax: (9 1 3) 752- 2111Indu s t ry In f orma t ion : WW'N.fda.gov/oc/ indus t ry- ANO 111\.EOf I


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0 [ PARTMNTOF HEAtT il Al"/0 HUMAN SERVICESfOOD AND DRUG ADMINISTRATIONO I S T ~ U < ; T AOOf!US" " " " " " " ' . . . ,. . ._ , . O A T ~ S IOo$'1!tTIOH11630 w. 80 t h St ree t 06/13/2011 - 07/0 8 /20 1 PLenexa, KS 66214 FEINUM8fH( 913 ) 75 2 - 2100 Fa x : (913) 75 2 - 211 1 191144 5Industry Information: www.fda.gov/oc/industrykANE AH0 TITLEOf IHOIVIOUAL TO V.HON REPQOIT ISSUEOTO : Terence J . Walsh, Site Leader

FIRIAHAIIE STREU AOORUSNovartis Consumer Health 10 401 Hwy 6CITY. ST4TE. l " ' COCE .COuHTIIY lYI'I! f.HT "'SI'ECT0Li ncoln, NE 68517 -9 626 Drug Manufacturer

.

/. . . .W,ffiSI-AT....o ~

OBSERVATION 13W r it ten records of major equipment c leaning, mai ntenance, and use are not included in individual equtpment logsSpecifica lly,Your Use Sequence Log, used to document packaging activity on non-dedicated equipment (line isnot always completed by your operators assigned to verify packaging line clearance.

Capsules (6/ 18/09) however, this was not completed.

There is no operator signature in the Use Sequence Log for "Dates ofMajor (wet) clean only" indicatingmajor cleans are conducted as required after a particular packaging run. Major cleans should have beendocumented on the forms after: Excedrin ES Tablets (6/10/09), Excedrin AFTH (6/11/09), Excedrin PM

T he example above is indica tive of how your firm currently operates with rcgord to filing out lineusage logs fo r all packaging lines.

*DATES OF INSPECT ION:06/1312011(Mon}, 06/ 14/2011(Tuc), 06/15/20 II (Wed}, 061171201 1(Fri), 06/2012011(Mon), 06/2112011(Tuc), 061221201 1(Wed).06/23/20 I I(Thu), 06/27/20 I I (Mon), 06129120 I I (Wed), 07/01/20 I I (r:"ri), 07/08/2011 Fri)

SEE REVERSEOF THIS PAGEEric M. Muel l er, Invest igatorJoseph R. Lamber t , Invest igator cr 45

O..l 1$$0

07/08/2011f ORM rD,\ ~ I . I I M I U I ) , . \llOOSUlmOf< n : INS PECTIONAI. OBSF.RVATIONS r > ~ G J u or . I ) r.-cr.s

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070811 483 redacted applied_Redacted-508.pdf