FDA 483 - Mylan Pharmaceuticals Inc. - January 07, 2016

The FDA issued a Form 483 to Mylan Pharmaceuticals Inc. following an inspection of their Morgantown, WV, finished drug product manufacturing facility from November 7 to 18, 2016. The document outlines several significant observations regarding adherence to Good Manufacturing Practices (GMP). Key issues included a lack of robust laboratory controls, particularly concerning data integrity. Inspectors observed analysts retesting out-of-specification or anomalous batch results without investigation, often leading to subsequent passing results. Practices like conducting unrecorded "trial injections" and altering sample sets without validated reasons were also noted. Furthermore, laboratory records were incomplete, with evidence of documents, chromatography data, and UV spectra being discarded or deleted. The firm also used expired chemicals and reference standards. There was a failure to thoroughly investigate discrepancies, with out-of-specification results repeatedly attributed to "glassware contamination" without effective resolution. Persistent manufacturing issues, such as "thick tablets" and tablet friability, were identified, yet products continued commercial distribution despite known problems and numerous dismissed consumer complaints. Additionally, critical test methods for process validation, regulatory submissions, and finished product testing were found to be unvalidated or validated retrospectively, long after product release. Complaint records were deficient, with subjective reviews leading to inappropriate invalidation of consumer reports, including misclassifying serious adverse events. Mylan Pharmaceuticals is obligated to implement comprehensive corrective actions to address these systemic non-conformities and ensure compliance with regulatory standards for drug product quality and safety.