# FDA 483 - BEO Pharma Inc - November 04, 2024

Source: https://www.keypedia.com/records/483/beo-pharma-inc/40edb0bf-c477-4981-826e-744fbf58af78

> FDA 483 for BEO Pharma Inc on November 04, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BEO Pharma Inc
- Inspection Date: 2024-11-04
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BEO Pharma Inc. dba BEO Pharmaceuticals Inc. in Brooksville, FL, revealed significant deficiencies across its quality control, laboratory, production, and materials systems. The firm failed to adequately follow quality unit procedures, ensure proper testing and release of drug products, establish sound laboratory controls, conduct process validations, and verify the identity of incoming raw materials. These issues indicate a lack of robust controls for manufacturing OTC drug products.

## Related Documents

- [483 - 2024-11-04](https://www.keypedia.com/records/483/beo-pharma-inc/dacc5d15-d1c5-4408-b541-16bbc85b1e21)
- [WARNING_LETTER - 2024-11-04](https://www.keypedia.com/records/warning_letter/beo-pharma-inc/408129b5-aeda-463b-a137-67a89d939d1a)

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.keypedia.com/companies/beo-pharma-inc/bc2943c1-de0c-4bf5-b29b-49563229a8fb

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