# FDA 483 - GCP Laboratories - May 13, 2022

Source: https://www.keypedia.com/records/483/gcp-laboratories/da0f3c7d-d446-4609-a44b-2217a030d808

> FDA 483 for GCP Laboratories on May 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GCP Laboratories
- Inspection Date: 2022-05-13
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: GCP Laboratories in Gulfport, MS, an OTC drug manufacturer, received a Form 483 with seven observations during an inspection from May 9-13, 2022. The observations highlight significant deficiencies in equipment maintenance, microbial control procedures, process validation, batch record documentation, material storage, quality control unit authority, and warehouse conditions. These issues indicate potential risks to drug product quality and purity.

## Related Officers

- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

Company: https://www.keypedia.com/companies/gcp-laboratories/4db6975e-4a27-4b14-b43c-6e61b5bc7db9

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