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Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning letter follows an inspection by the USFDA in June 2024 and highlights significant concerns about Data integrity issues and the Lack of Rigor in Out-of-specification (OOS) investigations. The facility was placed under an Import Alert by the FDA in December 2024.

Conclusion

Data integrity violations and inadequate failure investigations are serious cGMP deviations. Lapses lead to stringent regulatory actions requiring Firms to spend enormous amount of time and effort to assess all products, documents, investigations retrospectively impacting routine operations, business and reputation. Strong Quality culture, competent and strong management and effective management oversight with regular monitoring of operations and practices and prompt corrective actions are critical to ensure cGMP compliance and maintain regulators confidence.

Viatris Warning letter (December 2024)

Read All Qvents Posts on Topic Data Integrity

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