Finecure Pharmaceuticals LimitedNovember 22, 2024

FDA 483 - Finecure Pharmaceuticals Limited - November 22, 2024

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Record Details

An FDA inspection of Finecure Pharmaceuticals Limited in Ahmedabad, India, revealed a significant deficiency in their drug product stability program. The firm was cited for using a non-stability-indicating test method for assay of stability samples, which failed to analyze component degradation or impurities. This issue impacts the reliability of their stability testing, for which they are responsible under a quality agreement with their U.S. distributor.

Company: Finecure Pharmaceuticals Limited
Inspection Date: November 22, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Tekalign Wondimu ( Drug Investigator)

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