# FDA 483 - Macleods Pharmaceuticals Limited - May 26, 2023

Source: https://www.keypedia.com/records/483/macleods-pharmaceuticals-limited/fbf5bbb6-5580-46b4-91b3-2b71497b7787

> FDA 483 for Macleods Pharmaceuticals Limited on May 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Macleods Pharmaceuticals Limited
- Inspection Date: 2023-05-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Macleods Pharmaceuticals Limited in Daman, India, was cited for deficiencies in equipment design and control during an FDA inspection. Issues included checkweigher failures without proper batch record instructions, lack of dynamic airflow testing in manufacturing areas, and undefined critical alarms for automated equipment. The firm also failed to maintain complete lists of automated equipment recipes and lacked continuous monitoring for differential pressures, indicating a need for improved manufacturing process oversight.

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/macleods-pharmaceuticals-limited/784654e5-6e07-47f7-9806-dd8c32db2e1d

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