Jagsonpal Pharmaceuticals Limited

Warning LetterOpen

Mr. Manish Gupta Managing Director Jagsonpal Pharmaceuticals Limited Plot No. 412-415, Phase-IV Udyog Vihar Gurugram 122015 Haryana IndiaFEI 3004153045Issued Feb 5, 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 3004153045.

Violations3

Issue DateFeb 5, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Jagsonpal Pharmaceuticals Limited
Location: Mr. Manish Gupta Managing Director Jagsonpal Pharmaceuticals Limited Plot No. 412-415, Phase-IV Udyog Vihar Gurugram 122015 Haryana India
FEI Number: 3004153045
Country: India
Issue Date: February 05, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Jagsonpal Pharmaceuticals Limited received a warning letter for manufacturing adulterated active pharmaceutical ingredients (APIs) that failed to comply with Current Good Manufacturing Practice (CGMP) standards. During inspections conducted in March and April 2024, the FDA identified significant deviations including the company's failure to ensure its contract manufacturing organization (CMO) complied with CGMP requirements, and the use of an unregistered CMO that was not properly listed with the FDA as required by federal law. The company's quality unit failed to exercise adequate responsibility for overseeing manufacturing, processing, and packaging activities performed by the CMO, and the firm incorrectly declared itself as the manufacturer on import records while the actual CMO remained unregistered with the FDA.

Jagsonpal Pharmaceuticals Limited FDA Warning Letter, February 5, 2025