# FDA 483 - TriRx Huntsville Pharmaceutical Services, LLC - April 01, 2022

Source: https://www.keypedia.com/records/483/trirx-huntsville-pharmaceutical-services-llc/3cc0cfca-da41-428e-b501-67cd70f9d2ae

> FDA 483 for TriRx Huntsville Pharmaceutical Services, LLC on April 01, 2022. 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: 2022-04-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: TriRx Huntsville Pharmaceutical Services, LLC, a drug product manufacturer in Huntsville, AL, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate procedures to prevent objectionable microorganisms in drug products and a failure of the Quality Control Unit to properly investigate contamination sources and rejected materials. These issues indicate a serious lack of control over manufacturing processes and quality assurance.

## Related Documents

- [483 - 2014-12-19](https://www.keypedia.com/records/483/trirx-huntsville-pharmaceutical-services-llc/fcff31f5-6239-4b24-b66b-0b23a743cdd5)

## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)
- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab