# FDA 483 - Macleods Pharmaceuticals Limited - August 23, 2024

Source: https://www.keypedia.com/records/483/macleods-pharmaceuticals-limited/ef756df4-e3a5-49cd-8ef6-9328c8b92f25

> FDA 483 for Macleods Pharmaceuticals Limited on August 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Macleods Pharmaceuticals Limited
- Inspection Date: 2024-08-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Macleods Pharmaceuticals Limited, a drug manufacturer in Pithampur, India, was cited for three significant issues during an FDA inspection. Observations included a failure to thoroughly investigate equipment discrepancies, deficient complaint handling procedures for adverse events, and a lack of written procedures and oversight for critical water system alarms. These findings indicate a need for improved quality system controls and adherence to established procedures.

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/macleods-pharmaceuticals-limited/f7fe72e6-90d2-4daf-83eb-27fb2d948c3d

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