# FDA 483 - PMC Biogenix, Inc. - April 25, 2017

Source: https://www.globalkeysolutions.net/records/483/pmc-biogenix-inc/b7fcfe1b-374d-4c3a-8925-6bf2a0d96f94

> FDA 483 for PMC Biogenix, Inc. on April 25, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PMC Biogenix, Inc.
- Inspection Date: 2017-04-25
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of PMC Biogenix, an API manufacturer in Memphis, TN, revealed significant issues across three observations. The firm failed to validate the cleaning of truck trailers to prevent cross-contamination and exhibited deficiencies in its Quality Management Review process for Glycerin, USP. Additionally, equipment qualification was found to be inadequate, lacking demonstration of critical performance parameters.

## Related Officers

- [CO CDER OMQ](https://www.globalkeysolutions.net/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.globalkeysolutions.net/companies/pmc-biogenix-inc/01f14e73-d7ae-4ee7-853f-0d99b1ea8165

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