Belleview Biosciences LLC
Form 483 issued March 15, 2024 · Brooksville, Florida
- Inspection
- Feb 6 – Mar 15, 2024
- Investigator
- Michael H. Tollon
- Observations
- 7
- Pages
- 6
- FEI number
- 3005350897
In short: On March 15, 2024, FDA issued a Form 483 with 7 observations to Belleview Biosciences LLC in Brooksville, Florida (FEI 3005350897) after an inspection that ran Feb 6 – Mar 15, 2024. The investigator was Michael H. Tollon. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmBelleview Biosciences LLC history
All 6 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 Belleview Biosciences LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Belleview Biosciences LLC?
Michael H. Tollon is named on this Form 483, for the inspection of Feb 6 – Mar 15, 2024. Each investigator has a profile showing what they cite most.
When was Belleview Biosciences LLC inspected by FDA?
The inspection ran Feb 6 – Mar 15, 2024, and the Form 483 is dated March 15, 2024.
How do I get the full Form 483 for Belleview Biosciences LLC?
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.