Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-14.
At a glance
Inspections
10
Form 483s
3
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2025 – 14 Feb 2025 | Human Drugs | Clean | |
| 13 May 2024 – 17 May 2024 | Biologics | Clean | |
| 10 Apr 2023 – 18 Apr 2023 | Animal Drugs & Feeds | Clean | |
| 6 Jan 2020 – 17 Jan 2020 | Animal Drugs & Feeds | Clean | |
| 23 Jul 2018 – 3 Aug 2018 | Human Drugs | Clean | |
| 5 Mar 2015 – 8 Apr 2015 | Human Drugs | 483 | View 483 → |
| 6 Mar 2013 – 21 Mar 2013 | Animal Drugs & Feeds | 483 | On file |
| 11 Jan 2011 | Not recorded | Clean | |
| 30 Oct 2009 | Not recorded | 483 | On file |
| 20 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2015
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Janet L Bowen
Investigators
FDA investigators tied to this site in the record.
D'Arbra R Blankenship3 insp.
Stephen J Kilker2 insp.
Yiyue Zhang1 insp.
Yiyue C Zhang1 insp.
Mishelle L Harriger1 insp.
Yvette M Lacour-Davis1 insp.
Karen M Cooper1 insp.
Geoffrey K Kilili1 insp.
Janet L Bowen1 insp.
Karen M Kondas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.185(a)(13) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Charles River Laboratories Ashland, LLC's 3 Form 483s
Source PDFs 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