# FDA 483 - TriRx Huntsville Pharmaceutical Services, LLC - December 19, 2014

Source: https://www.keypedia.com/records/483/trirx-huntsville-pharmaceutical-services-llc/fcff31f5-6239-4b24-b66b-0b23a743cdd5

> FDA 483 for TriRx Huntsville Pharmaceutical Services, LLC on December 19, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TriRx Huntsville Pharmaceutical Services, LLC
- Inspection Date: 2014-12-19
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals in Huntsville, AL, identified a significant quality control deficiency. The firm failed to reject finished drug product batches that did not meet established in-process specifications. Additionally, reprocessing of these non-conforming batches was not performed, indicating a serious lapse in product quality assurance.

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## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)

Company: https://www.keypedia.com/companies/trirx-huntsville-pharmaceutical-services-llc/bdf3220b-2a57-4125-b4ef-af4d1d9c9fa8

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