Data Integrity violations and ineffective Quality systems

In December 2024, the U.S. FDA issued a Warning Letter to the US American company "Viatris, Inc." after having inspected its Indian site "Mylan Laboratories Limited, Inc., a Viatris company" in June 2024.

The significant violations of CGMP regulations for finished products, which are mentioned in the Warning Letter, are listed as follows:

• "Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d))."
• "Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)."

Especially, the first observation mentioned in the Warning Letter is related to the enormous lack of Data Integrity, essentially Lab Data Integrity. This finding lists that "Biometric access records documented that the responsible analysts were not physically present at the facility during testing. Despite their absence, they documented both the testing process and results as if they had conducted the analyses.". It is also explained that after FDA's inspection at the Indian site and as a response to the received Form FDA 483, the company expanded their Data Integrity investigations and identified that also the facility's Site Head of Quality, Head of Quality Control, Head of Quality Assurance, Head of Investigations, and the Manager responsible for the packaging materials laboratory distrained the Data Integrity policies of the company. According to the Warning Letter this personnel has been removed from the company's organisation in the meantime.

The second observation lists the breaches of CGMP requirements related to handling of OOS, OOT and other unexpected results and the missing oversight of the Quality Unit. According to the Warning Letter the investigations were inadequate and the conclusions insufficient.

The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements not only limited to the Indian site and demonstrated that the company "does not operate an effective quality system in accord with CGMP". It is stated in the Warning Letter that "in addition to the lack of effective management oversight of their laboratory operations, the FDA found the QU is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities." That's why the U.S. FDA Warning Letter advised that the "executive management should immediately and comprehensively assess the company's global manufacturing operations to ensure that the systems, processes, and products conform to FDA requirements."

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a consultant to support the company in aligning their systems with CGMP requirements and reminds the company to conduct a review of all Quality Assurance program audits within the last five years at all their facilities.
Additionally, in December 2024, the U.S. FDA placed the company's products on import alert and may refuse new applications or supplements listing the company as drug manufacturer until the site has addressed all observations and fully complies with CGMP requirements. This might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Viatris, Inc.