FDA 483 - Catalent Indiana LLC - July 14, 2025

During an inspection from September 18 to October 25, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Mylan Inc. for significant deviations from current Good Manufacturing Practices (cGMP) at its Morgantown, WV facility. The inspection highlighted three main concerns requiring the company's attention.

Firstly, Mylan Inc. failed to consistently follow its established written procedures for cleaning validation of non-dedicated manufacturing equipment. Specifically, for Triamterene and Hydrochlorothiazide Capsules, only two of the required three validation runs were completed, a repeat observation from a previous inspection, raising concerns about potential product cross-contamination (21 CFR 211.67(b)).

Secondly, laboratory controls were found to be inadequate. Between January 2022 and September 2023, Mylan invalidated 59 initial Out of Specification (OOS) results for finished product tests without sufficient scientific justification. Many OOS results were attributed to analyst error without conclusive evidence, as exemplified by issues with Albuterol Sulfate Inhalation Aerosol and Perphenazine Tablets, impacting product quality assurance (21 CFR 211.160(b)(4)).

Lastly, investigations into unexplained discrepancies and the effectiveness of Corrective and Preventive Actions (CAPAs) were deficient. CAPAs designed to address recurring analyst errors or product mix-ups, such as a foreign tablet finding, were not always effective, indicating a lack of thorough root cause analysis and sustained corrective measures (21 CFR 211.192).

Mylan Inc. must comprehensively address these observations to ensure full compliance with regulatory standards and maintain the quality and purity of its pharmaceutical products.