BPI Labs LLC
FDA inspection history in Largo, Florida, 2021 to 2026
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one Form 483; 2025: one warning letter and one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Largo, Florida.
- 2025–26Two Form 483s and one warning letter, at Largo, Florida.
- 2026The longest 483 on file: 4 observations over 8 pages at Largo, Florida.
Cited most
Across all BPI Labs observations on file
- 21 CFR 41
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
The complete BPI Labs file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Largo, Florida
Three Form 483s and one warning letter · 2021 to 2026 · 8 observations
Latest: Form 483, Apr 17, 2026 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-17 | 483 Form 483 | Largo, Florida | 4 | $99 |
| 2025-03-20 | Warning letter Warning letter | Largo, Florida | — | $99 |
| 2025-02-21 | 483 Form 483 | Largo, Florida | 1 | $99 |
| 2021-04-30 | 483 Form 483 | Largo, Florida | 3 | $99 |
Investigators on these documents
Emma R. Schaefer (1)Jessica L. Pressley (1)Lisa R. Hilliard (1)Logan T. Williams (1)Nicole E. Knowlton (1)Saundrea A. Munroe (1)
FEI number 3015156709 · most recent document Apr 17, 2026
About BPI Labs LLC
How many FDA Form 483s has BPI Labs LLC received?
FDA Intel has 3 Form 483s on file for BPI Labs LLC; the most recent is dated Apr 17, 2026.
When was BPI Labs LLC last inspected by FDA?
The most recent FDA inspection document on file for BPI Labs LLC is a Form 483 dated Apr 17, 2026, for the site in Largo, Florida.
What did FDA cite at BPI Labs LLC?
The regulations cited most in the observations on file for BPI Labs LLC are 21 CFR 4, 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.166 (Stability testing), 1 time.
Has BPI Labs LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for BPI Labs LLC; the most recent is dated Mar 20, 2025.