FDA 483 - BEO Pharma Inc - November 04, 2024

This FDA Form 483 was issued to BEO Pharma Inc. dba BEO Pharmaceuticals Inc., a drug manufacturer located at 16255 Aviation Loop Dr, Brooksville, FL, following an inspection from October 16 to November 4, 2024. The owner, Amanda S. Ambrose, was the recipient.

The inspection revealed five observations related to quality, laboratory, production, and materials systems:

1. **Quality System Deficiencies:** The quality control unit's responsibilities and procedures were not fully followed. This included failing to identify and investigate batch record errors (e.g., releasing a batch without yield calculation or complete finished product test results), lacking quality oversight for controlled written procedures (e.g., unapproved CEO changes to the Validation Master Plan), not performing process validation for numerous OTC drug products manufactured since November 2023, and not adhering to written procedures for collecting reserve samples of incoming raw materials.

2. **Inadequate Drug Product Release Testing:** Drug products were released and distributed without complete finished product testing. For example, a lot was shipped two days before receiving final microbiological test results from a third-party laboratory.

3. **Insufficient Laboratory Controls:** Laboratory controls lacked scientifically sound test procedures. Specifically, outsourced microbiological test methods for OTC finished drug products were not evaluated for their suitability or capability to recover objectionable organisms.

4. **Failure to Establish Production Procedures:** The firm failed