# Mylan Laboratories Limited – FDA 483, Jul 10, 2026

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited/ffbde96c-3131-4580-bd35-c7a49a38d215

> FDA 483 for Mylan Laboratories Limited on July 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2026-07-10
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Mylan Laboratories Limited, a sterile drug manufacturer in Bangalore, India, revealed significant deficiencies across multiple areas of its operations. Observations included inadequate aseptic practices, environmental monitoring, and batch record documentation. The firm also failed to adequately test incoming components, qualify a critical supplier, and conduct thorough investigations into product discrepancies, indicating potential risks to product quality and sterility.

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## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/mylan-laboratories-limited/977203cc-5cbe-49ea-9b42-0b797ade4b5e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8