Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-21.
At a glance
Inspections
11
Form 483s
6
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 21 Mar 2025 | Human Drugs | 483 | View 483 → |
| 26 Jul 2021 – 30 Jul 2021 | Biologics | Clean | |
| 11 Jun 2018 – 15 Jun 2018 | Human Drugs | 483 | On file |
| 22 May 2017 – 26 May 2017 | Human Drugs | 483 | On file |
| 9 Jan 2017 – 13 Jan 2017 | Human Drugs | 483 | On file |
| 21 Sep 2015 – 25 Sep 2015 | Human Drugs | 483 | On file |
| 25 Jul 2012 | Not recorded | Clean | |
| 23 Oct 2009 | Not recorded | 483 | On file |
| 23 May 2007 | Not recorded | Clean | |
| 8 Jul 2004 | Not recorded | Clean | |
| 12 Dec 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Mar 2025
21 CFR 58.185(a)(6)
Final report: description of methods
Cited by Samson O Oluseye, Audrey J Yarbrough
21 Mar 2025
21 CFR 58.185(a)(7)
Final report: description of test system
Cited by Samson O Oluseye, Audrey J Yarbrough
21 Mar 2025
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Samson O Oluseye, Audrey J Yarbrough
15 Jun 2018
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Sandra S Saniga, Zhou Chen
Investigators
FDA investigators tied to this site in the record.
Edward D Harris2 insp.
Samson O Oluseye1 insp.
Audrey J Yarbrough1 insp.
Humberto Z Gomez1 insp.
Dustin P Tran1 insp.
Rebecca T Davis1 insp.
Sandra S Saniga1 insp.
Zhou Chen1 insp.
Himanshu Gupta1 insp.
Melkamu Getie Kebtie1 insp.
Kara A Scheibner1 insp.
Amanda Lewin1 insp.
Xiaohan Cai1 insp.
Thea C Grome1 insp.
Stuart W Russell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.120(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Charles River Laboratories, Inc.'s 6 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