Belleview Biosciences LLC
FDA inspection history in Brooksville, Florida, 2017 to 2024
- 4
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2017: one Form 483; 2019: one warning letter and one Form 483; 2021: one Form 483; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–21Three Form 483s and one warning letter, at Brooksville, Florida.
- 2017The longest 483 on file: 9 observations over 8 pages at Brooksville, Florida.
- 2024One warning letter and one Form 483, at Brooksville, Florida.
Cited most
Across all Belleview Biosciences observations on file
- 21 CFR 211.160(b)General requirements4
- 21 CFR 211.165(a)Testing and release for distribution4
- 21 CFR 211.22(a)Responsibilities of quality control unit4
- 21 CFR 211.63Equipment design, size, and location4
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures3
The complete Belleview Biosciences file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Brooksville, Florida
Four Form 483s and two warning letters · 2017 to 2024 · 26 observations
Latest: Warning letter, Aug 6, 2024 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-06 | Warning letter Warning letter | Brooksville, Florida | — | $99 |
| 2024-03-15 | 483 Form 483 | Brooksville, Florida | 7 | $99 |
| 2021-08-20 | 483 Form 483 | Brooksville, Florida | 4 | $99 |
| 2019-08-01 | Warning letter Warning letter | Brooksville, Florida | — | $99 |
| 2019-02-15 | 483 Form 483 | Brooksville, Florida | 6 | $99 |
| 2017-01-25 | 483 Form 483 | Brooksville, Florida | 9 | $99 |
Investigators on these documents
Michael H. Tollon (1)Nicole E. Knowlton (1)Saundrea A. Munroe (1)
FEI number 3005350897 · most recent document Aug 6, 2024
About Belleview Biosciences LLC
How many FDA Form 483s has Belleview Biosciences LLC received?
FDA Intel has 4 Form 483s on file for Belleview Biosciences LLC; the most recent is dated Mar 15, 2024.
When was Belleview Biosciences LLC last inspected by FDA?
The most recent FDA inspection document on file for Belleview Biosciences LLC is a Form 483 dated Mar 15, 2024, for the site in Brooksville, Florida.
What did FDA cite at Belleview Biosciences LLC?
The regulations cited most in the observations on file for Belleview Biosciences LLC are 21 CFR 211.160(b) (General requirements), 4 times; 21 CFR 211.165(a) (Testing and release for distribution), 4 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 4 times.
Has Belleview Biosciences LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Belleview Biosciences LLC; the most recent is dated Aug 6, 2024.