BEO Pharma Inc. dba BEO Pharmaceuticals
Form 483 issued November 4, 2024 · Brooksville, Florida
- Inspection
- Oct 16 – Nov 4, 2024
- Investigator
- Kayla V. Sprague
- Observations
- 5
- Pages
- 5
- FEI number
- 3027036172
In short: On November 4, 2024, FDA issued a Form 483 with 5 observations to BEO Pharma Inc. dba BEO Pharmaceuticals in Brooksville, Florida (FEI 3027036172) after an inspection that ran Oct 16 – Nov 4, 2024. The investigator was Kayla V. Sprague. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Testing and release of ding product for distribution do not include appropriate laboratory determination of satisfactoiy…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmBEO Pharma Inc. dba BEO Pharmaceuticals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BEO Pharma Inc. dba BEO Pharmaceuticals?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected BEO Pharma Inc. dba BEO Pharmaceuticals?
Kayla V. Sprague is named on this Form 483, for the inspection of Oct 16 – Nov 4, 2024. Each investigator has a profile showing what they cite most.
When was BEO Pharma Inc. dba BEO Pharmaceuticals inspected by FDA?
The inspection ran Oct 16 – Nov 4, 2024, and the Form 483 is dated November 4, 2024.
How do I get the full Form 483 for BEO Pharma Inc. dba BEO Pharmaceuticals?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.