Acharya ChemicalsMarch 15, 2024

FDA 483 - Acharya Chemicals - March 15, 2024

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Record Details

Acharya Chemicals, a manufacturer in Thane, India, was cited for significant deficiencies in its quality control processes. The inspection revealed a failure to adequately investigate out-of-specification (OOS) results and implement appropriate corrective and preventive actions. This indicates a critical lapse in ensuring product quality and process control.

Company: Acharya Chemicals
Inspection Date: March 15, 2024
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Clinton J. Lott (Investigator)

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ID · 880b9b79-3656-4b37-9d4c-ee7e0000447f