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# Quality, Data Issues at Mylan Facility in India
- URL: https://www.fdaweb.com/quality-data-issues-at-mylan-facility-in-india/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158373

A 6/14-6/26/2024 FDA inspection at Viatris’ Mylan Laboratories drug manufacturing facility in Madhya, Pradesh, India, found multiple violations, including significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/19/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/viatris-inc-690897-12192024?ref=fdaweb.com) says specific violations were:

- failure to establish and follow adequate written responsibilities and procedures applicable to the quality control unit; and
- failure 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 had already been distributed.

The letter says the findings indicate that Mylan does not operate an effective quality system following CGMPs. FDA strongly recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements. The letter also cites a need for data integrity remediation and a review of all quality assurance program audits and inspections within the last five years at all facilities maintained by Viatris, Mylan’s corporate owner.

Products from the Mylan Pradesh facility were placed on a 12/19 Import Alert. The company was told to correct violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.