# FDA 483 - Macleods Pharmaceuticals Limited - October 20, 2023

Source: https://www.keypedia.com/records/483/macleods-pharmaceuticals-limited/24719885-17b2-4812-8dbf-1a797866f892

> FDA 483 for Macleods Pharmaceuticals Limited on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Macleods Pharmaceuticals Limited
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Macleods Pharmaceuticals Limited, a non-sterile drug manufacturer in Baddi, India, was cited for multiple significant deficiencies during an FDA inspection. Repeat observations included inadequate cleaning procedures and insufficient computer system controls. The firm also failed to ensure proper stability testing, quality control review of records, and timely Field Alert Report submission, indicating a broad range of quality system issues.

## Related Documents

- [483 - 2021-11-01](https://www.keypedia.com/records/483/macleods-pharmaceuticals-limited/9d34b67a-474a-41b3-b282-b8baf29864f3)

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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

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