Centaur Pharmaceuticals Private Ltd.

Warning LetterOpen

Mr. Shashikant Sonaje President and Site Head Centaur Pharmaceuticals Private Ltd. Plot No.4, International Biotech Park, Phase-II, Hinjewadi Pune 411057 Maharashtra IndiaFEI 3008861619Issued Jul 25, 2023Center for Drug Evaluation and Research | CDER

View Letter

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 3008861619.

Violations2

Issue DateJul 25, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Centaur Pharmaceuticals Private Ltd.
Location: Mr. Shashikant Sonaje President and Site Head Centaur Pharmaceuticals Private Ltd. Plot No.4, International Biotech Park, Phase-II, Hinjewadi Pune 411057 Maharashtra India
FEI Number: 3008861619
Country: India
Issue Date: July 25, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Centaur Pharmaceuticals Private Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of finished pharmaceutical drugs following an FDA inspection in January-February 2023. The company failed to adequately clean, maintain, and sanitize manufacturing equipment and utensils, with inspectors identifying residues of different products on direct and indirect product contact surfaces and discovering that certain equipment sections had not been cleaned or examined for cleanliness in over 14 years. These deficiencies rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, as their methods, facilities, and controls did not conform to required manufacturing standards.

Centaur Pharmaceuticals Private Ltd. FDA Warning Letter, July 25, 2023