483
Chemspec Chemicals Private LimitedChemspec Chemicals Private Limited – FDA 483, Aug 1, 2025
Record Details
An FDA inspection of Chemspec Chemicals Private Limited, an API manufacturer in Navi Mumbai, India, revealed significant deficiencies across multiple areas. The firm failed to maintain adequate batch records, control document issuance, ensure proper quality unit oversight, validate test procedures for raw materials, conduct thorough investigations, and contemporaneously record quality-related activities. Additionally, cleaning procedures and their documentation were found to be deficient.
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