FDA WARNING_LETTER - Mylan Laboratories Limited – Unit 7 - February 28, 2020

The FDA inspected Mylan Laboratories Limited, Unit 7, in India, from February 24-28, 2020, identifying significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Inadequate Cleaning Procedures:** The facility lacked adequate cleaning records for approximately 100 non-dedicated bulk storage tanks prior to October 2019. Cleaning validation and verification programs for non-dedicated equipment were also insufficient, specifically failing to detect and quantify certain impurities. This raises concerns about cross-contamination, especially with recovered solvents from a contract manufacturing organization (CMO) previously cited for inadequate impurity profiles. 2. **Failure to Control Recovered Solvents:** Mylan failed to implement procedures to evaluate and control impurity risks in recovered solvents. Unknown peaks in chromatograms of recovered solvents were not thoroughly evaluated, indicating a lack of comprehensive impurity profiling and monitoring.

The FDA found Mylan's responses to be inadequate, noting that testing alone is insufficient to mitigate contamination hazards and that their evaluation of unknown peaks was not comprehensive. The letter highlights repeat deviations at multiple Mylan facilities, demonstrating inadequate company-wide oversight. The FDA strongly recommends engaging a CGMP consultant. Failure to correct these deviations may result in withheld new drug approvals, refusal of admission of articles into the U.S., and potential drug shortages. Mylan must respond within 15 working