# FDA 483 - UK Health Security Agency - May 25, 2021

Source: https://www.globalkeysolutions.net/records/483/uk-health-security-agency/ba15b5bc-4ff4-427a-b29a-9c4580e53b78

> FDA 483 for UK Health Security Agency on May 25, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: UK Health Security Agency
- Inspection Date: 2021-05-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Public Health England was inspected by the FDA, revealing significant deficiencies in its laboratory control systems. The inspection found issues with data integrity, specifically the lack of protection for raw data from alteration or deletion in computerized systems and the absence of audit trail review procedures. Additionally, the firm failed to establish adequate written procedures for investigating invalid host cell protein (HCP) assays.

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [investigator](https://www.globalkeysolutions.net/people/tracy-denison/2690d043-2209-4437-999c-634af9ae63cc)

Company: https://www.globalkeysolutions.net/companies/uk-health-security-agency/7dd3f141-301f-4e8c-a6f8-8bdae50b5493

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