# Mylan Laboratories Limited (FDF-2) – FDA 483, Aug 25, 2026

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited-fdf-2/09b1a8a3-d1e1-4e0e-a996-3f6b9669015e

> FDA 483 for Mylan Laboratories Limited (FDF-2) on August 25, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited (FDF-2)
- Inspection Date: 2026-08-25
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Mylan Laboratories Limited (FDF-2) in Chhatrapati Sambhajinagar, India, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. The inspection revealed critical failures including inadequate investigations into out-of-specification results and delayed product recalls, widespread data integrity issues in laboratory and batch records, and poor equipment cleaning practices. These findings indicate a severe lack of control over drug product quality and a high risk of non-conforming products reaching the U.S. market.

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/mylan-laboratories-limited-fdf-2/1bcb64f5-f3f2-412e-81da-b3efab26f310

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3