# FDA 483 - Belcher Pharmaceuticals, LLC - November 15, 2021

Source: https://www.keypedia.com/records/483/belcher-pharmaceuticals-llc/0502d62a-ca12-487b-8b27-f8286b775310

> FDA 483 for Belcher Pharmaceuticals, LLC on November 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Belcher Pharmaceuticals, LLC
- Inspection Date: 2021-11-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Belcher Pharmaceuticals, LLC in Largo, FL, revealed significant deficiencies in laboratory controls, production and process controls, batch recordkeeping, quality unit responsibilities, and facility maintenance. The firm failed to verify testing methods, lacked written procedures for critical processes, had incomplete batch records, and did not ensure proper quality unit oversight. Additionally, basic facility requirements like hot water in restrooms were not met, indicating a broad range of issues impacting drug product quality and safety.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/belcher-pharmaceuticals-llc/e04d8e92-7dd3-4727-8892-ce1eb036b77f)
- [483 - 2022-11-04](https://www.keypedia.com/records/483/belcher-pharmaceuticals-llc/863c5017-bb5f-423b-a090-ea14f1b0e8f0)
- [483 - 2024-08-16](https://www.keypedia.com/records/483/belcher-pharmaceuticals-llc/6261ec39-958d-4a13-a3a9-5a02cb5f6126)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/belcher-pharmaceuticals-llc/a75a45a4-abd8-4594-aa7c-0ef90a92f9aa

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6