Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2026 – 17 Apr 2026 | Human Drugs | 483 | View 483 → |
| 14 Apr 2025 – 23 Apr 2025 | Human Drugs | 483 | View 483 → |
| 10 Feb 2025 – 21 Feb 2025 | Human Drugs | 483 | View 483 → |
| 19 Apr 2021 – 30 Apr 2021 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Apr 2026
FDCA 503B(a)(2)
Bulk drug substances, cannot be used in compounding
Cited by Lisa R Hilliard
23 Apr 2025
FDCA 505-1(f)(3)(A)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
Cited by Emily A Baldwin, Chinyere A Asanya
Investigators
FDA investigators tied to this site in the record.
Lisa R Hilliard1 insp.
Emily A Baldwin1 insp.
Chinyere A Asanya1 insp.
Nicole E Knowlton1 insp.
Logan T Williams1 insp.
Jessica L Pressley1 insp.
Saundrea A Munroe1 insp.
Emma R Schaefer1 insp.
Jessica P Mcalister1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BPI Labs, LLC's 4 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat