# FDA EIR - Mylan Laboratories Limited - June 26, 2024

Source: https://www.keypedia.com/records/eir/mylan-laboratories-limited/da336daf-5994-4cde-aef3-179db73b3a70

> FDA EIR for Mylan Laboratories Limited on June 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2024-06-26
- Product Type: drugs
- Summary: An unannounced Good Manufacturing Practice (GMP) inspection of Mylan Laboratories Limited, located in Pithampur, India, was conducted by the FDA from June 14 to June 26, 2024. This inspection, focusing on the company's manufacturing of various drug products for the USA market, evaluated compliance with drug manufacturing regulations (CPGM 7356.002, Drug Process Inspection). The inspection revealed six significant violations, resulting in an FDA Form 483 issuance. Key issues included inadequate cleaning intervals for equipment, failure to thoroughly investigate unexplained discrepancies or batches not meeting specifications, and deficiencies in laboratory controls such as sampling plans and test procedures. Furthermore, the Quality Control unit did not fully adhere to its responsibilities and procedures, controls over computer systems for record changes were insufficient, and actual versus theoretical yields were not consistently determined at each manufacturing phase. These observations led to an "Official Action Indicated (OAI)" classification for the inspection, with a recommendation for a Warning Letter. Mylan Laboratories Limited's management committed to addressing the observations and providing a written response within 15 business days, outlining their corrective actions.

## Related Documents

- [EIR - 2024-06-26](https://www.keypedia.com/records/eir/mylan-laboratories-limited/bc84d86e-7c72-4b35-babf-5a42beca8bcf)
- [483 - 2024-06-26](https://www.keypedia.com/records/483/mylan-laboratories-limited/87897492-4940-476d-9c33-d87c45e038b2)
- [483 - 2024-06-26](https://www.keypedia.com/records/483/mylan-laboratories-limited/8d80a740-a39c-41f1-a0fe-76664c670680)
- [483 - Unknown Date](https://www.keypedia.com/records/483/mylan-laboratories-limited/1b851ed2-a51f-4583-a5fc-46d5c3d0ab99)

## Related Officers

- [recipient](https://www.keypedia.com/people/pramod-kumar-singh/1547bb16-d6c0-4be2-bda0-d7d54e8b3396)
- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [issuing_officer](https://www.keypedia.com/people/stephen-j-mottola/a35bf779-9edb-40a3-93c8-1ac43808dccf)
- [Compliance Officer, CDER, Office of Manufacturing](https://www.keypedia.com/people/joseph-r-lambert/d2968fda-8e5e-433a-b60b-f68aaef3b7b0)

Company: https://www.keypedia.com/companies/mylan-laboratories-limited/b7da9cbd-d5e3-417f-a485-f9e38852b256