Mr. Manoj Sharma
Country President & Director of Operations
Centrient Pharmaceuticals India Private Limited
Bhai Mohan Singh Nagar, Toansa Dist. SBS Nagar
Nawanshahr 144533
Punjab
IndiaFEI 3004497364Issued Dec 7, 2022Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004497364.
Violations0
Issue DateDec 7, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Centrient Pharmaceuticals India Private Limited
Location
Mr. Manoj Sharma
Country President & Director of Operations
Centrient Pharmaceuticals India Private Limited
Bhai Mohan Singh Nagar, Toansa Dist. SBS Nagar
Nawanshahr 144533
Punjab
India
FEI Number
3004497364
Country
India
Issue Date
December 07, 2022
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Centrient Pharmaceuticals India Private Limited, an active pharmaceutical ingredient (API) manufacturer in Punjab, was cited for significant current good manufacturing practice (CGMP) violations that rendered their APIs adulterated. FDA investigators documented failures in quality unit oversight, including inadequate document control with uncontrolled storage of logbooks and forms, improper handling of documents in an unlabeled emergency shredder, and insufficient controls over computerized systems with multiple users sharing login credentials. These deficiencies represented a systemic breakdown in the company's ability to ensure API compliance with manufacturing standards during the June-July 2022 inspection.
Centrient Pharmaceuticals India Private Limited FDA Warning Letter, December 7, 2022
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