Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-20.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2023 – 20 Sep 2023 | Human Drugs | WL | View 483 → |
| 27 Nov 2012 | Not recorded | Clean | |
| 15 Jul 2011 | Not recorded | Clean | |
| 15 May 2009 | Not recorded | 483 | View 483 → |
| 18 Nov 2005 | Not recorded | Clean | |
| 24 Nov 2003 | Not recorded | Clean | |
| 18 Jun 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michelle A Krayer, Shelby N Turner
20 Sep 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michelle A Krayer, Shelby N Turner
20 Sep 2023
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Michelle A Krayer, Shelby N Turner
Investigators
FDA investigators tied to this site in the record.
Michelle A Krayer1 insp.
Shelby N Turner1 insp.
Stephen D Brown1 insp.
Cntrctmntr Martinez1 insp.
Anh Lac1 insp.
Elisa M Fleming1 insp.
Martha S Baldwin1 insp.
Gwendolyn F Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | 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(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ARG Laboratories, Inc.'s 2 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