FDA 483 - Tianish Laboratories Private Limited - March 16, 2018

An FDA inspection of Mylan Laboratories Limited (Units 1/2) conducted from March 12-16, 2018, resulted in a Form 483 detailing significant deviations from good manufacturing practices for Active Pharmaceutical Ingredients. The main violations included a compromised quality system, where out-of-specification investigations lacked scientific justification, and critical quality events like corrective actions, change controls, and customer complaints were not closed within required timeframes, often without proper justification for extensions. The company also failed to adequately qualify suppliers or establish necessary quality agreements.

Facility and equipment maintenance were deficient, with observations of peeling paint, cracks, dirty vents, corroded machinery, and improper storage of cleaned items, leading to potential contamination risks. Employees in quality control and production lacked a full understanding of their assigned functions, indicating inadequate training. Furthermore, production and laboratory procedures were not consistently followed, evident in unrecorded pH readings, undocumented equipment cleaning, and poorly controlled laboratory environments, including unlabeled glassware and insufficient testing of the water system.

These observations highlight a systemic need for Mylan Laboratories to implement robust corrective actions across its quality, production, and laboratory systems to comply with the Federal Food, Drug, and Cosmetic Act and prevent potential product contamination or quality issues.