# FDA 483 - Packpharm Limited - September 01, 2023

Source: https://www.keypedia.com/records/483/packpharm-limited/f17190ce-05a7-4de4-af03-70e3ba959c8a

> FDA 483 for Packpharm Limited on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Packpharm Limited
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Packpharm Limited in Norwich, United Kingdom, was inspected by the FDA, revealing significant deficiencies across laboratory controls, manufacturing process validation, and facility maintenance. The firm failed to establish adequate specifications for drug product impurities and dissolution, did not properly qualify equipment for manufacturing, and maintained a warehouse in a poor state of repair with observed stains, cracks, and insects. These issues indicate a lack of robust quality systems to ensure drug product quality and facility integrity.

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/packpharm-limited/6289e413-3a35-4f76-9a93-6a7e5996c159

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