Belleview Biosciences LLC
Form 483 issued February 15, 2019 · Brooksville, Florida
- Inspection
- Dec 17, 2018 – Feb 15, 2019
- Investigator
- Saundrea A. Munroe
- Observations
- 6
- Pages
- 6
- FEI number
- 3005350897
In short: On February 15, 2019, FDA issued a Form 483 with 6 observations to Belleview Biosciences LLC in Brooksville, Florida (FEI 3005350897) after an inspection that ran Dec 17, 2018 – Feb 15, 2019. The investigator was Saundrea A. Munroe. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 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
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) 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 6 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.
Who inspected Belleview Biosciences LLC?
Saundrea A. Munroe is named on this Form 483, for the inspection of Dec 17, 2018 – Feb 15, 2019. Each investigator has a profile showing what they cite most.
When was Belleview Biosciences LLC inspected by FDA?
The inspection ran Dec 17, 2018 – Feb 15, 2019, and the Form 483 is dated February 15, 2019.
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.