# FDA 483 - Oxford Pharmaceuticals, LLC - May 22, 2019

Source: https://www.keypedia.com/records/483/oxford-pharmaceuticals-llc/12185de3-9376-4a55-8a10-b505825c82f9

> FDA 483 for Oxford Pharmaceuticals, LLC on May 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxford Pharmaceuticals, LLC
- Inspection Date: 2019-05-22
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Oxford Pharmaceuticals, LLC in Birmingham, AL, revealed significant deficiencies in their quality control unit, including a failure to conduct required Quality Management Review meetings and inadequate supplier auditing. The firm also lacked established procedures to prevent objectionable microorganisms in non-sterile drug products, specifically concerning their water generation plant. Additionally, deviations from written specifications and test procedures in their contracted microbiology laboratory were not justified.

## Related Documents

- [483 - 2023-11-03](https://www.keypedia.com/records/483/oxford-pharmaceuticals-llc/d7066e3b-80a9-49c8-bb95-75cc0bc54434)

## Related Officers

- [Investigator/Consumer Safety Officer](https://www.keypedia.com/people/francis-a-guidry/fd6d2a17-7f94-4f7c-8284-ad1f07d703e9)

Company: https://www.keypedia.com/companies/oxford-pharmaceuticals-llc/5294310a-05a2-4599-bf9e-720929f040ee

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9