Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-04-18.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2019 – 18 Apr 2019 | Animal Drugs & Feeds | 483 | On file |
| 22 Feb 2016 – 4 Mar 2016 | Animal Drugs & Feeds | Clean | |
| 3 Apr 2012 | Not recorded | 483 | On file |
| 10 Feb 2012 | Not recorded | 483 | On file |
| 3 Feb 2010 | Not recorded | Clean | |
| 26 Jan 2006 | Not recorded | Clean | |
| 17 Jun 2003 | Not recorded | Clean | |
| 19 Oct 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Apr 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Ileana Barreto-Pettit
18 Apr 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Ileana Barreto-Pettit
18 Apr 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Ileana Barreto-Pettit
18 Apr 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Ileana Barreto-Pettit
18 Apr 2019
21 CFR 211.166(a)
Written program not followed
Cited by Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit1 insp.
Lorie S Hannappel1 insp.
Noreen Muniz1 insp.
Iram R Hassan1 insp.
Kim L Thomas Cruse1 insp.
Thomas E Friel1 insp.
Melanie M Walker1 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 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Norbrook Laboratories, Ltd.'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