483
Unilab Chemicals and Pharmaceuticals Private Ltd.Unilab Chemicals and Pharmaceuticals Private Ltd. – FDA 483, Feb 27, 2026
Record Details
An FDA inspection of Unilab Chemicals and Pharmaceuticals Private Ltd. in Mumbai, India, revealed significant deficiencies in its API manufacturing processes. The firm failed to ensure supplier reliability, adequately investigate discrepancies, maintain proper quality control documentation, and provide sufficient GMP training. A repeat observation highlighted persistent issues with equipment cleaning, indicating a lack of control over contamination prevention.
- Inspection date
- February 27, 2026
- Product type
- drugs
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ID · a079994a-782f-418b-acac-04cf84434b7e
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