FDA 483 - Finecure Pharmaceuticals Limited - November 22, 2024

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.