Sri Krishna Pharmaceuticals Limited - Unit IVApril 11, 2025

FDA 483 - Sri Krishna Pharmaceuticals Limited - Unit IV - April 11, 2025

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Record Details

Sri Krishna Pharmaceuticals Limited, an API manufacturer in Sangareddy, Telangana, received a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate investigations into discrepancies, a deficient quality control unit with poor data integrity practices, and unsuitable manufacturing equipment. These issues indicate a lack of robust controls over critical manufacturing and quality processes.

Company: Sri Krishna Pharmaceuticals Limited - Unit IV
Inspection Date: April 11, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Clinton J. Lott (Investigator)
Andre Cadre
Arsen Karapetyan

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ID · 625f5a8f-d9c0-47ca-8b03-cedf769431b3