FDA 483 - BE Pharmaceuticals Private Ltd. - June 12, 2014

This FDA Form 483 report details significant data integrity and quality control failures at Akorn India PVT, a sterile drug product manufacturer in Paonta Sahib, India. Inspectors found widespread falsification of laboratory testing records for sterility, water analysis, environmental monitoring, biological indicators, bioburden, bacterial endotoxins, and media fills. Additionally, the firm exhibited inadequate personnel training, poor change control, uninvestigated discrepancies, and deficiencies in laboratory controls, facility design, document control, warehousing, and equipment cleaning.