# FDA 483 - Qualitest Pharmaceuticals - August 01, 2014

Source: https://www.keypedia.com/records/483/qualitest-pharmaceuticals/e67d6b11-f667-44a3-8b60-ad186017ef80

> FDA 483 for Qualitest Pharmaceuticals on August 01, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qualitest Pharmaceuticals
- Inspection Date: 2014-08-01
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Qualitest Pharmaceuticals in Huntsville, AL, resulted in a Form 483 with two observations. The firm was cited for plumbing system defects that could lead to drug product contamination due to microbial growth in the water system. Additionally, the inspection revealed a failure to thoroughly review unexplained discrepancies and batch failures, including not rejecting batches with confirmed stability issues and an inadequate investigation into out-of-calibration equipment.

## Related Officers

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

Company: https://www.keypedia.com/companies/qualitest-pharmaceuticals/241f6923-906b-4948-89f6-17d472c0ea4e

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