# FDA 483 - TriRx Huntsville Pharmaceutical Services, LLC - June 15, 2026

Source: https://www.keypedia.com/records/483/trirx-huntsville-pharmaceutical-services-llc/7a6bf5f2-b53b-4a78-93cc-181cad1da2a9

> FDA 483 for TriRx Huntsville Pharmaceutical Services, LLC on June 15, 2026. 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: 2026-06-15
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: TriRx Huntsville Pharmaceutical Services, LLC, a drug manufacturer in Huntsville, AL, was inspected and cited for multiple significant deficiencies. Observations included inadequate complaint handling, lack of validated cleaning procedures, unestablished test method accuracy, insufficient process validation, and improper equipment calibration. These issues indicate a systemic failure in maintaining a state of control over critical manufacturing and quality control processes.

## Related Documents

- [483 - 2014-12-19](https://www.keypedia.com/records/483/trirx-huntsville-pharmaceutical-services-llc/fcff31f5-6239-4b24-b66b-0b23a743cdd5)
- [483 - 2022-04-01](https://www.keypedia.com/records/483/trirx-huntsville-pharmaceutical-services-llc/3cc0cfca-da41-428e-b501-67cd70f9d2ae)

## Related Officers

- [Jeffrey T. Prosterman](https://www.keypedia.com/people/jeffrey-t-prosterman/1343bea3-692d-484e-b29f-c9f8f052f09c)

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
