# FDA 483 - Belcher Pharmaceuticals, LLC - November 04, 2022

Source: https://www.keypedia.com/records/483/belcher-pharmaceuticals-llc/863c5017-bb5f-423b-a090-ea14f1b0e8f0

> FDA 483 for Belcher Pharmaceuticals, LLC on November 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Belcher Pharmaceuticals, LLC
- Inspection Date: 2022-11-04
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Belcher Pharmaceuticals, LLC in Largo, FL, was inspected by the FDA, resulting in two observations related to inadequate laboratory controls and insufficient investigation records. The firm failed to prevent potential contamination of drug product ingredients and did not adequately investigate out-of-specification results, raising concerns about product quality and data reliability.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/belcher-pharmaceuticals-llc/e04d8e92-7dd3-4727-8892-ce1eb036b77f)
- [483 - 2021-11-15](https://www.keypedia.com/records/483/belcher-pharmaceuticals-llc/0502d62a-ca12-487b-8b27-f8286b775310)
- [483 - 2024-08-16](https://www.keypedia.com/records/483/belcher-pharmaceuticals-llc/6261ec39-958d-4a13-a3a9-5a02cb5f6126)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [issuing_officer](https://www.keypedia.com/people/harshal-j-desai/9ccefb1f-95fc-4a17-9647-eecb5c3ce838)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

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