Overview
- 16 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-16.
At a glance
Inspections
16
Form 483s
7
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 16 Jan 2026 | Human Drugs | Clean | |
| 4 Nov 2024 – 7 Nov 2024 | Human Drugs | Clean | |
| 26 Jan 2022 – 17 Feb 2022 | Human Drugs | 483 | View 483 → |
| 31 Oct 2019 – 15 Nov 2019 | Human Drugs | Clean | |
| 26 Oct 2017 – 6 Nov 2017 | Human Drugs | 483 | On file |
| 28 Nov 2016 – 6 Dec 2016 | Human Drugs | 483 | On file |
| 12 Aug 2014 – 15 Aug 2014 | Human Drugs | Clean | |
| 8 Jun 2012 | Not recorded | 483 | On file |
| 2 Mar 2012 | Not recorded | 483 | View 483 → |
| 18 Feb 2011 | Not recorded | 483 | On file |
| 28 Oct 2008 | Not recorded | 483 | On file |
| 20 Sep 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Feb 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Edmund F Mrak, Ko U Min
17 Feb 2022
21 CFR 211.186(a)
Master production and control records, procedure
Cited by Edmund F Mrak, Ko U Min
17 Feb 2022
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Edmund F Mrak, Ko U Min
Investigators
FDA investigators tied to this site in the record.
Russell J Glapion2 insp.
Frederick Razzaghi2 insp.
Nicholas A Violand2 insp.
Gam S Zamil1 insp.
Alisha B Patel1 insp.
Young K Chou1 insp.
Sam Pepe1 insp.
Edmund F Mrak1 insp.
Ko U Min1 insp.
Adetutu M Gidado1 insp.
Meyer J Slobotsky1 insp.
Justine Tomasso1 insp.
Kevin P Foley1 insp.
Karen E Dorazio1 insp.
Daniel J Grabicki1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Guardian Drug Co. 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