Chemspec Chemicals Private Limited

Warning LetterOpen

Mr. Rushabh Vora Managing Director Chemspec Chemicals Private Limited Plot 3-C, Taluka Panvel Navi Mumbai 410208 Maharashtra India ccpl@chemspec.co.inFEI 3004947391Issued Dec 23, 2025Center for Drug Evaluation and Research (CDER)

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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 3004947391.

Violations4

Issue DateDec 23, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Chemspec Chemicals Private Limited
Location: Mr. Rushabh Vora Managing Director Chemspec Chemicals Private Limited Plot 3-C, Taluka Panvel Navi Mumbai 410208 Maharashtra India ccpl@chemspec.co.in
FEI Number: 3004947391
Country: India
Issue Date: December 23, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Chemspec Chemicals Private Limited, an active pharmaceutical ingredient (API) manufacturer in India, was found to be producing adulterated drugs due to significant Current Good Manufacturing Practice (CGMP) deviations during an FDA inspection in July 2025. The company's quality unit failed to exercise adequate oversight and control, including inadequate document control of batch production records, failure to maintain complete manufacturing records for multiple API lots prior to distribution, and insufficient enforcement of data integrity principles among employees. The facility manufactured and released API lots without proper batch records and did not identify these critical deficiencies until cited by FDA investigators during the inspection.

Chemspec Chemicals Private Limited FDA Warning Letter, December 23, 2025