Belleview Biosciences LLC
Form 483 issued August 20, 2021 · Brooksville, Florida
- Inspection
- Aug 16 – Aug 20, 2021
- Observations
- 4
- Pages
- 7
- FEI number
- 3005350897
In short: On August 20, 2021, FDA issued a Form 483 with 4 observations to Belleview Biosciences LLC in Brooksville, Florida (FEI 3005350897) after an inspection that ran Aug 16 – Aug 20, 2021. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
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
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Questions about this 483
What did FDA find at Belleview Biosciences LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Belleview Biosciences LLC inspected by FDA?
The inspection ran Aug 16 – Aug 20, 2021, and the Form 483 is dated August 20, 2021.
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.