Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-29.
At a glance
Inspections
11
Form 483s
7
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2026 – 29 May 2026 | Foods & Cosmetics | Clean | |
| 24 Apr 2023 – 28 Apr 2023 | Human Drugs | 483 | View 483 → |
| 25 Oct 2022 – 6 Dec 2022 | Foods & Cosmetics | 483 | View 483 → |
| 3 May 2016 – 12 May 2016 | Foods & Cosmetics | 483 | View 483 → |
| 8 Apr 2013 – 7 May 2013 | Foods & Cosmetics | 483 | On file |
| 2 Aug 2012 | Not recorded | 483 | View 483 → |
| 3 Jun 2011 | Not recorded | 483 | View 483 → |
| 31 Dec 2008 | Not recorded | WL | View 483 → |
| 13 Jun 2007 | Not recorded | Clean | |
| 2 Jun 2005 | Not recorded | WL | |
| 30 Jan 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Apr 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Nicole E Knowlton, Steven A Brettler
28 Apr 2023
21 CFR 211.192
No written record of investigation
Cited by Nicole E Knowlton, Steven A Brettler
28 Apr 2023
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Nicole E Knowlton, Steven A Brettler
28 Apr 2023
21 CFR 211.63
Equipment Design, Size and Location
Cited by Nicole E Knowlton, Steven A Brettler
6 Dec 2022
21 CFR 111.105(d)
Quality control - basis; tests, examinations
Cited by Aaron J Fox, Karl D Hezel, Miguel A Martinez
Investigators
FDA investigators tied to this site in the record.
Michael H Tollon3 insp.
Karl D Hezel2 insp.
Jennifer A Robinson1 insp.
Megan K Otero1 insp.
Brittany C Smith1 insp.
Nicole E Knowlton1 insp.
Steven A Brettler1 insp.
Aaron J Fox1 insp.
Miguel A Martinez1 insp.
Tracy L Reed1 insp.
Rodney W Lenger1 insp.
David P King1 insp.
Samantha J Pinizzotto1 insp.
Daryl A Dewoskin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(k)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(E) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.90(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 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 |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ion Labs Inc.'s 7 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