Overview
- 18 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
18
Form 483s
12
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2025 – 9 May 2025 | Biologics | 483 | View 483 → |
| 31 Oct 2022 – 4 Nov 2022 | Biologics | 483 | On file |
| 5 Nov 2018 – 9 Nov 2018 | Human Drugs | 483 | View 483 → |
| 5 Jun 2018 – 8 Jun 2018 | Human Drugs | Clean | |
| 21 Feb 2018 – 28 Feb 2018 | Biologics | 483 | On file |
| 3 Apr 2017 – 14 Apr 2017 | Human Drugs | 483 | View 483 → |
| 14 Dec 2015 – 18 Dec 2015 | Biologics | 483 | On file |
| 6 Jul 2015 – 14 Jul 2015 | Human Drugs | Clean | |
| 12 Aug 2013 – 23 Aug 2013 | Human Drugs | 483 | View 483 → |
| 18 Jan 2013 | Not recorded | 483 | On file |
| 26 Jul 2012 | Not recorded | Clean | |
| 25 Aug 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Apr 2017
21 CFR 211.101(c)
Weighing/measuring/subdividing supervision
Cited by Jonathan W Chapman, Marcus A Ray
Investigators
FDA investigators tied to this site in the record.
Brooke K Higgins4 insp.
Ernest Bizjak4 insp.
Brian R Yaun3 insp.
Marcus A Ray2 insp.
Scott T Ballard1 insp.
Thomas R Withers1 insp.
Eileen A Liu1 insp.
Qin Xu1 insp.
Simone E Pitts1 insp.
Fabian N Chaparro-Rodriguez1 insp.
Jonathan W Chapman1 insp.
Debra M Emerson1 insp.
Zhongren Wu1 insp.
Toyin B Oladimeji1 insp.
Eric L Dong1 insp.
Susan M Jackson1 insp.
Burnell M Henry1 insp.
Sam Pepe1 insp.
Carrie L Doupnik1 insp.
Gang Wang1 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 | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | 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 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Barr Laboratories Inc.'s 12 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