Overview
- 12 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-08.
At a glance
Inspections
12
Form 483s
11
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Apr 2024 – 8 May 2024 | Biologics | 483 | View 483 → |
| 3 Oct 2023 – 6 Oct 2023 | Foods & Cosmetics | 483 | View 483 → |
| 27 Mar 2023 – 6 Apr 2023 | Human Drugs | 483 | View 483 → |
| 18 Oct 2021 – 22 Oct 2021 | Human Drugs | 483 | View 483 → |
| 11 Jun 2019 – 14 Jun 2019 | Human Drugs | 483 | View 483 → |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | View 483 → |
| 27 Apr 2015 – 1 May 2015 | Human Drugs | 483 | View 483 → |
| 21 Apr 2014 – 25 Apr 2014 | Human Drugs | 483 | View 483 → |
| 17 Jun 2013 – 24 Jun 2013 | Human Drugs | 483 | View 483 → |
| 26 Sep 2011 | Not recorded | 483 | On file |
| 20 Mar 2009 | Not recorded | 483 | View 483 → |
| 23 Oct 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 May 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
8 May 2024
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
8 May 2024
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
8 May 2024
21 CFR 211.84(d)(3)
Establish reliability of supplier's C of A
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
6 Oct 2023
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Thomas R Withers, Cody D Rickman, Jogy George
Investigators
FDA investigators tied to this site in the record.
Brooke K Higgins4 insp.
Jonathan W Chapman2 insp.
Brentley S Collins1 insp.
Laurel A Beer1 insp.
Brentley S Pittman1 insp.
Thomas R Withers1 insp.
Cody D Rickman1 insp.
Jogy George1 insp.
Jonah S Ufferfilge1 insp.
Amy N Chen1 insp.
Saleem A Akhtar1 insp.
Kristina L Conroy1 insp.
William J Leonard1 insp.
Gayle S Lawson1 insp.
Marcus A Ray1 insp.
Anastasia M Shields1 insp.
Junho Pak1 insp.
Luis A Dasta1 insp.
Paula J Bretz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.410(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Afton Scientific, LLC's 11 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