FDA WARNING_LETTER - Viatris Inc. - June 26, 2024

The FDA issued a Warning Letter to Mylan Laboratories Limited, Inc., "a Viatris company," following an inspection from June 14-26, 2024, at their Indore, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to establish and follow adequate quality control unit procedures (21 CFR 211.22(d))**: Investigators found data integrity anomalies in component release testing, where analysts documented testing and results despite not being physically present. Mylan's response acknowledged unreliable data and removed responsible personnel, but FDA deemed it inadequate due to insufficient detail on the extent of issues and proposed CAPAs. FDA noted Mylan's awareness of these issues since January 2024, prior to the inspection. 2. **Failure to thoroughly investigate discrepancies or failures (21 CFR 211.192)**: Investigations into OOS/OOT results lacked scientific rationale. Examples included aborted HPLC sequences for (b)(4) mg tablets and invalidated OOT assay results for (b)(4) mg Capsules without proper justification or audit trail evidence. Mylan's acknowledgment of inadequate investigations was deemed insufficient by FDA.

The FDA requires comprehensive corrective actions, including a complete assessment of documentation