Alok K. Garg
Managing Director
Medgel Private Limited
Plot No.: 19-20, Special Economic Zone, Phase-II, Sector-III
Pithampur 454775
Madhya Pradesh
IndiaFEI 3010165392Issued Jul 20, 2023Center 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 3010165392.
Violations4
Issue DateJul 20, 2023
Product TypeDrugs
StatusClosed
Closeout LetterMay 29, 2025
Letter Details
Firm
Medgel Private Limited
Location
Alok K. Garg
Managing Director
Medgel Private Limited
Plot No.: 19-20, Special Economic Zone, Phase-II, Sector-III
Pithampur 454775
Madhya Pradesh
India
FEI Number
3010165392
Country
India
Issue Date
July 20, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Closed
Closeout Letter
May 29, 2025
Summary
Medgel Private Limited, a drug manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter capsule products. During a January 2023 inspection, the FDA identified that the company failed to adequately investigate out-of-specification (OOS) test results, particularly by invalidating results without sufficient scientific justification and attributing failures to sample preparation errors without proper hypothesis testing or evidence. The firm subsequently retested and released batches after obtaining passing results, rendering the drug products adulterated under federal law.
Medgel Private Limited FDA Warning Letter, July 20, 2023
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