# FDA 483 - Macleods Pharmaceuticals Limited - November 01, 2021

Source: https://www.globalkeysolutions.net/records/483/macleods-pharmaceuticals-limited/9d34b67a-474a-41b3-b282-b8baf29864f3

> FDA 483 for Macleods Pharmaceuticals Limited on November 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Macleods Pharmaceuticals Limited
- Inspection Date: 2021-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Macleods Pharmaceuticals Limited, a drug product manufacturer in District Solan, India, revealed significant Good Manufacturing Practice deficiencies. Repeated observations included inadequate equipment cleaning procedures leading to drug product residue and potential cross-contamination, and deficient Out-of-Specification investigations lacking scientific rationale. Other findings involved unvalidated cleaning processes, insufficient risk assessments for impurities, failed process performance qualifications, poor computer system controls, and facility maintenance issues.

## Related Documents

- [483 - 2023-10-20](https://www.globalkeysolutions.net/records/483/macleods-pharmaceuticals-limited/24719885-17b2-4812-8dbf-1a797866f892)

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/macleods-pharmaceuticals-limited/cd51cd03-2afe-4dcd-93b4-20beee9d0521

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1