Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-01-15.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 15 Jan 2026 | Human Drugs | Clean | |
| 16 Oct 2025 – 20 Oct 2025 | Biologics | Clean | |
| 3 Sep 2020 – 4 Sep 2020 | Human Drugs | Clean | |
| 20 Apr 2015 – 22 Apr 2015 | Human Drugs | Clean | |
| 26 Jul 2012 | Not recorded | 483 | View 483 → |
| 3 Feb 2010 | Not recorded | Clean | |
| 9 Aug 2005 | Not recorded | Clean | |
| 20 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak2 insp.
Ogechi C Nna1 insp.
Lewis K Antwi1 insp.
Robert C Horan1 insp.
Charisse K Green1 insp.
Paul E Stein1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bionique Testing Laboratories LLC's 1 Form 483
Verbatim observations 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