FDA 483 - Strides Pharma, Inc. - June 04, 2015

Par Pharmaceutical Inc. in Spring Valley, NY, was cited for significant deficiencies in its quality control unit, laboratory controls, and adherence to written procedures during an FDA inspection. Observations included inadequate investigations into product complaints and contamination, failure to thoroughly review discrepancies, and issues with method validation and stability testing programs. These findings indicate a lack of robust quality systems to ensure drug product identity, strength, quality, and purity.