Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-25.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2025 – 25 Apr 2025 | Human Drugs | 483 | View 483 → |
| 14 Nov 2019 – 21 Nov 2019 | Human Drugs | 483 | View 483 → |
| 14 Nov 2016 – 18 Nov 2016 | Human Drugs | 483 | View 483 → |
| 31 May 2012 | Not recorded | 483 | On file |
| 10 Jun 2010 | Not recorded | 483 | View 483 → |
| 24 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Apr 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Martin M Kimani, Rafeeq A Habeeb
18 Nov 2016
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Lindsey M Schwierjohann, Lauren N Howard, Lauren N Smith, David S Jackson
Investigators
FDA investigators tied to this site in the record.
Martin M Kimani1 insp.
Rafeeq A Habeeb1 insp.
Jon P Antoniou1 insp.
Lindsey M Schwierjohann1 insp.
Lauren N Howard1 insp.
Lauren N Smith1 insp.
David S Jackson1 insp.
Tracey L Harris1 insp.
Elizabeth L Edwards1 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 | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Q LABS, LLC's 5 Form 483s
Source PDFs, 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