US FDA Warning Letters of CAPA Violations: A Review

Author(s): Pavan Deshpande, Rutuja Agawane, Sarath C. Tatikola, Surenahalli G. Vasantharaju*

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 2 , 2020


DOI : 10.2174/2213476X06666191015114427

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Graphical Abstract:


Abstract:

United States Food and Drug Administration (USFDA) is a federal agency functioning under United States Federal Executive Departments, which strives to regulate the food products and drug substances being manufactured or brought into US market, upholding Quality and Safety as prime goals. It takes care of its goals by inspecting firms which market products in the United States. It chalks out good manufacturing procedures for obtaining quality end-products. Based on inspections conducted and data collected thereby, those not abiding by rules shall be issued with Warning Letters and marketing license shall be cancelled for those who fail to justify the warning letter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to be achieved to survive in market.

Keywords: CAPA, USFDA, warning letters, US healthcare, violations, regulated markets.

[1]
Spring S,, Limited L,. Complex BK food TUS. Lupin Limited 2018;; 351(2): :1-7.
[2]
Gopalkrishnan VN. Malladi drugs & pharmaceuticals Ltd2018 Available from: https://www.fda.gov/inspections-complianceenforce- ment-and-criminal-investigations/warning-letters/malladi-drugs-pharmaceuticals-ltd-541915-03092018
[3]
Rajiv M. Mylan laboratory limited, (Nashik FDF) Available from: https://www.fda.gov/inspections-compliance enforcement-and-criminal-investigations/ warning-letters/mylan-laboratories-limited-nashik-fdf-517906-04032017
[4]
Wu Z. Hangzhou face care cosmetic co, Ltd 2017 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/hangzhou-facecare-cosmetics-co-ltd-537146-11172017
[5]
Fedeli E. Warning letter Tubilux pharma spa 2017 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/tubilux-pharma-spa-523119-07062017
[6]
Dalborg FO. Boule medical AB 2018 Available from: https://www.fda.gov/inspections-compliance-enforce-ment-and-criminal-investigations/warning-letters/boule-medical-ab-559614-10022018
[7]
Mehta K. Tris pharma Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tris-pharma-inc-534537-03262018
[8]
Rauer H. Aussimed Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aussimed-ltd-03032016
[9]
Whitehurst M. Mibo medical group 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-lett ers/mibo-medical-group-558900-11202018
[10]
Bresch H. Mylan pharmaceuticals Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/mylan-pharmaceuticals-inc-557903-11092018
[11]
Bashford CM. 86 Harriet Ave corporation DBA general 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/86-harriet-ave-corporation-dba-general-devices-475178-06012016
[12]
Cortinovis GM. ARCOS 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/arcos-srl-08032016
[13]
Delforge J, Group A. Alseal 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/alseal-507073-11102016
[14]
Rauer H. Aussimed Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/aussimed-ltd-03032016
[15]
Prantsidis D. DMP Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/dmp-ltd-03042016
[16]
Nath Hindustan syringes & medical devices 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/hindustan-syringes-medical-devices-ltd-494040-05132016
[17]
Cho S. Incyto co Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/incyto-co-ltd-497916-10252018
[18]
Cohen SE. Innovative sterilization technologies LLC 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/innovative-sterlization-technologies-llc-03022016
[19]
Huang G. Master and frank Ent co Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/master-and-frank-ent-co-ltd-481365-05102016
[20]
Martin S. Spectranetics corporation 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spectranetics-corporation-05232016
[21]
Seidel R. TYRX Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/tyrx-inc-06022016
[22]
Papa JC. Valeant pharmaceuticals nternational 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/valeant-pharmacueticals-international-06132017
[23]
Han Y. Denttio Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/denttio-inc-04102018
[24]
Abeles MF. Diasol east Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce-ment-and-criminal-investigations/warning-letters/diasol-east-inc-522511-07122017
[25]
Anthony TS. Kelyniam global, Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kelyniam-global-inc-527408-10052017
[26]
Henkemans T. International petersburg booth ProSun international LLC 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/prosun-international-llc-539273-10252017
[27]
Wu J. Qinhuangdao Zizhu pharmaceutical, co 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/qinhuangdao-zizhu-pharmaceutical-co-517793-04242017
[28]
Novikov D. Telemed 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/telemed-540646-05242019
[29]
The See Clear Company 2018. Available from:. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000MultidisciplineR.pdf
[30]
Singh G. D, Bio modeling solutions, Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/biomodeling-solutions-inc-540821-01122018
[31]
Delapalme PL. Br sas 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/br-sas-542617-06082018
[32]
Dube CG. Cardiomed supplies, Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-let ters/cardiomed-supplies-inc-564967-09212018
[33]
Sepulveda AL. Jabones Y Productos Especializados SA de 2018 Available from https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/jabones-y-productos-especializados-sa-de-cv-558088-09052018
[34]
Yoon DH. Kolmar Korea Co 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kolmar-korea-co-ltd-542511-05182018
[35]
Feinberg HA. Laser dental innovations 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/laser-dental-innovations-546341-02272018
[36]
Ishrak O. Medtronic Inc 2018 Available from: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-cardiac-resynchronization-therapy-and-implantable-cardioverter-defibrillators-due
[37]
Souhaut E. Quali controle & Qual-controle-CE Bac 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/quali-controle-qual-controle-cebac-542283-03052018.
[38]
Anders MG L. E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh 2017 Available from: https://www. fda.gov/inspections-compliance-enforcement-and-cri-minal-investigations/ warning-letters/g-l-e-gesellschaft-fur-lichttechnische-erzeugnisse-mbh-508514-02232017Studienzentr F G L E. 483(Fda 483)2008; 2-6.
[39]
Qunfeng Y. Yangzhou Hengyuan daily chemical 2018 Available from: https://www.fda.gov/inspect ions-compliance-enforcement-and-criminal-investigations/warning-letters/yangzhou-hengyuan-daily-chemical-plastic-co-ltd-505482-09262016
[40]
Sodha F. Spiegelberg Gmbh & co KG 2018 Available from: https://www.fda.gov/inspections-comp-liance-enforcement-and-criminal-investigations/warn ing-letters/spiegelberg-gmbh-co-kg-08032016
[41]
Teva pharmaceutical works private 2018 Available from: https://www.fda.gov/safety/recalls-market-with drawals-safety-alerts/teva-pharmaceuticals-usa-issues-voluntary-nationwide-recall-valsartan-and-valsartan
[42]
Neguyen RN. BioChem laboratories Inc 2018 Available from: https://www.fda.gov/inspections-comp liance-enforcement-and-criminal-investigations/warn ing-letters/bb-biochem-laboratories-inc-552896-07032018
[43]
Arora C. JT cosmetics & chemicals Pvt Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/jt-cosmetics-chemicals-pvt-ltd-554478-07272018
[44]
Sama AF. Aplicare Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/aplicare-inc-489281-12152016
[45]
Wu L. Implant dental technology co Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/implant-dental-technology-co-ltd-506873-10252016
[46]
Yee Q. Teva pharmaceutical and chemical 2017Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/teva-pharmaceutical-and-chemical-hangzhou-co-ltd-516381-04052017
[47]
Medoff DH. Trimed Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trimed-inc-06302016
[48]
Pasini A. Lonza Walkersville, Inc 2018 Available from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lonza-walkersville-inc-520239-04212017
[49]
Min K. Opto-Pharm Pte Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforce-ment-and-criminal-investigations/warning-letters/op-to-pharm-pte-ltd-517254-03162017
[50]
Hinton RJ. Porton biopharma limited 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-lett ers/porton-biopharma-limited-509689-01172017
[51]
Song JK. Beauty manufacturing solutions corp 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/beauty-manufacturing-solutions-corp-535116-01122018
[52]
Kee WS. Celltrion Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celltrion-inc-534262-01262018
[53]
Cohen SE. Innovative sterilization technologies LLC 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/innovative-sterlization-technologies-llc-03022016
[54]
Kim JJ. Hanlim pharm Co, Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/hanim-pharm-co-ltd-553021-10032018
[55]
Margoosian R. Lernapharm (Loris) Inc 2018 Available from: https://www.fda.gov/inspections-complia nce-enforcement-and-criminal-investigations/warning -letters/lernapharm-loris-inc-552525-09042018
[56]
Wu H C. Cheng Fong chemical Co Ltd, 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/cheng-fong-chemical-co-ltd-506380-09152016
[57]
Rassoli K. Diamo Dent 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/diamodent-01052016.
[58]
Howieson M. Helica Instruments, Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/helica-instruments-ltd-05132016.
[59]
Ibrahim E. Horizon Pharmaceuticals, Inc 2018Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/horizon-pharmaceuticals-inc-485363-02192018
[60]
Emmanuel EM. Implants international Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/implants-international-ltd-02182016
[61]
Jordan DM. Miami fat supply, Inc 2018 Available from: https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/warning-let ters/miami-fat-supply-inc-01192018
[62]
Nelson J. Omega laser systems 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/om-ega-laser-systems-02172016
[63]
Food and drug administration Poly drug laboratories Pvt 2016 Available from: http://www.fda.gov/ICECI/EnforcementActions/War ning Letters/2016/ucm496623.htm
[64]
Qiagen Sciences LLC. 2018 Available from: https://www.fda.gov/medical-devices/medical-device-recalls/qiagen-sciences-llc-recalls-amnisure-rom-test-due-lack-control-line-may-lead-misinterpretation-test
[65]
Massicotte Y. Ropack, Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ropack-inc-499580-04232018
[66]
Appel Feinkost GmbH &co KG 2018 Available from: https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/warningletters/appel-feinkost-gmbh-co-kg-524654-03272018
[67]
Parekh MJ. Unimark remedies limited 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/unimark-remedies-limited-08122016
[68]
Casas SB. Braun medical Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/b-braun-medical-inc-501232-05122017
[69]
Baumann W, Ag B. Bayer pharma AG 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/bayer-pharma-ag-526288-11142017
[70]
Kei CM. Bebe toys manufactory Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-let ters/bebe-toys-manufactory-ltd-512794-04062017
[71]
Jha N. Criticare technologies Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/criticare-technologies-inc-523101-04212017
[72]
Jariwala K. CTX life sciences private Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/ctx-lifesciences-private-ltd-496393-10052018
[73]
Henrikkson M. Fresenius Kabi oncology limited 2008 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/ warning-letters/fresenius-kabi-oncology-ltd-538641-12042017
[74]
Reed IC. Hospira Inc 2017 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/hospira-inc-506761-02142017
[75]
Oif KN. National biological corp 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/national-biological-corp-523732-07112017
[76]
Brown DS. Sage products Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/sage-products-inc-520382-07172017
[77]
Ito Y. Sato pharmaceutical Co, Ltd 2018 Available from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sato-pharmaceutical-co-ltd-511905-02022017
[78]
Tewari PK. USV limited 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usv-limited-510159-02142018
[79]
Gibson CB. Vidco Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/vidco-inc-516295-05052017
[80]
Morris DL. Whitehall / div of acorn engineering Co 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/whitehalldiv-acorn-engineering-co-525297-07122017
[81]
Velumani TG. Alchymars ICM SM private limited 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/alchymars-icm-sm-private-limited-542879-02162018
[82]
Kumar R. Apotex research private limited 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-research-private-limited-547439-08092018
[83]
Anand SP. Bio diagnostic international 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/bio-diagnostic-international-554322-07122018.
[84]
Ryu R. Dexcowin Co 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/dexcowin-co-ltd-545388-02202018
[85]
Apps DL. Gaeltec devices LTD 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/gaeltec-devices-ltd-554344-07022018
[86]
Martin I. Jalco cosmetics Pty Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-en forcement-and-criminal-investigations/warning-letters /jalco-cosmetics-pty-ltd-546939-05182018
[87]
Hanson B. Zimmer Biomet Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/zimmer-biomet-inc-558176-08242018
[88]
Taylor C. Berwickshire electronic manufacturing 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/berwickshire-electronic-manufacturing-ltd-02042016
[89]
Rubinstein Y, Cia SRL. 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/fp-rubinstein-y-cia-srl-05052016
[90]
Godha P. Ipca laboratories limited 2016 Available from: https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/warningletters/ipca-laboratories-limited-01292016
[91]
Beech PL, Isolux LLC. 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isolux-llc-01082016
[92]
Bourassa M. Savaria concord lifts, Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/savaria-concord-lifts-inc-498435-08032016
[93]
Leach G. Delta laboratories pty Ltd 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/delta-laboratories-pty-ltd-537641-12192017
[94]
Vyas A. Claris injectables limited 2018 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/claris-injectables-limited-543187-07052018
[95]
Fernandez GR, Degasa SA, De CV. 2018 Available from: https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/warningletters/degasa-sa-de-cv-542521-04182018
[96]
Yen E. Diamond wipes international, Inc 2018 Available from: https://www.fda.gov/inspectionscompliance-enforcement-and-criminal-investigations/ warning-letters/diamond-wipes-international-inc-534290-03072018
[97]
Dishman AM. ITG-Medev Inc 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/itgmedev-inc-562975-09072018
[98]
Raut DK. Keshava organics Pvt 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/keshava-organics-pvt-ltd-540146-03152018
[99]
Spooner GT. US vascular LLC 2018 Available from: https://www.fda.gov/inspections-compliance-enforce ment-and-criminal-investigations/warning-letters/us-vascular-llc-554761-06072018


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Article Details

VOLUME: 7
ISSUE: 2
Year: 2020
Published on: 15 October, 2019
Page: [85 - 92]
Pages: 8
DOI: 10.2174/2213476X06666191015114427

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