Belleview Biosciences LLC
Form 483 issued January 25, 2017 · Brooksville, Florida
- Inspection
- Jan 3 – Jan 25, 2017
- Investigator
- Nicole E. Knowlton
- Observations
- 9
- Pages
- 8
- FEI number
- 3005350897
In short: On January 25, 2017, FDA issued a Form 483 with 9 observations to Belleview Biosciences LLC in Brooksville, Florida (FEI 3005350897) after an inspection that ran Jan 3 – Jan 25, 2017. The investigator was Nicole E. Knowlton. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Belleview Biosciences LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Belleview Biosciences LLC?
Nicole E. Knowlton is named on this Form 483, for the inspection of Jan 3 – Jan 25, 2017. Each investigator has a profile showing what they cite most.
When was Belleview Biosciences LLC inspected by FDA?
The inspection ran Jan 3 – Jan 25, 2017, and the Form 483 is dated January 25, 2017.
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.