FDA 483 - Anicare Pharmaceuticals Pvt Ltd. - August 03, 2018

Anicare Pharmaceuticals Pvt Ltd. in Navi Mumbai, India, a drug product manufacturer, was cited for significant deficiencies across its manufacturing and quality control operations. Observations included failures in thoroughly reviewing discrepancies, inadequate process validation, deficient master production records, lack of homogeneity demonstration, unsupported cleaning validation, and unsuitable stability testing programs. These issues indicate a broad lack of control over critical aspects of drug product quality and safety.