# FDA 483 - University of Alabama at Birmingham - August 27, 2019

Source: https://www.globalkeysolutions.net/records/483/university-of-alabama-at-birmingham/6b82740d-7529-44dc-8ccb-02f745158ca5

> FDA 483 for University of Alabama at Birmingham on August 27, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: University of Alabama at Birmingham
- Inspection Date: 2019-08-27
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: The UAB Cyclotron PET Production Facility in Birmingham, AL, was cited for significant deficiencies in its PET drug manufacturing operations. Observations included inadequate record-keeping and data integrity controls for electronic records, unsuitable laboratory analytical methods, and a lack of robust production and process controls. Additionally, the firm failed to ensure equipment suitability and proper maintenance, and did not adequately review production records for errors.

## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.globalkeysolutions.net/companies/university-of-alabama-at-birmingham/4e588b2e-2487-4557-a6a2-787531855709

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea