Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-18.
At a glance
Inspections
12
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2024 – 18 Apr 2024 | Human Drugs | 483 | View 483 → |
| 5 Feb 2020 – 20 Feb 2020 | Human Drugs | 483 | View 483 → |
| 12 Dec 2018 – 21 Dec 2018 | Human Drugs | Clean | |
| 18 Jul 2016 – 29 Jul 2016 | Human Drugs | 483 | On file |
| 12 May 2014 – 20 May 2014 | Human Drugs | 483 | View 483 → |
| 29 Mar 2012 | Not recorded | 483 | On file |
| 14 Mar 2011 | Not recorded | 483 | View 483 → |
| 21 Jan 2010 | Not recorded | 483 | View 483 → |
| 26 Feb 2009 | Not recorded | Clean | |
| 19 Mar 2008 | Not recorded | 483 | On file |
| 11 Aug 2006 | Not recorded | Clean | |
| 12 Jun 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2020
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Noreen Muniz, Ivis L Negron Torres
20 Feb 2020
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Noreen Muniz, Ivis L Negron Torres
20 Feb 2020
21 CFR 211.160(b)(2)
Acceptance of in-process materials
Cited by Noreen Muniz, Ivis L Negron Torres
Investigators
FDA investigators tied to this site in the record.
Noreen Muniz4 insp.
Jose A Cruz Gonzalez3 insp.
Libia M Lugo2 insp.
Raquel Gonzalez Rivera2 insp.
Ivis L Negron Torres1 insp.
Rebeca M Melendez1 insp.
Jose F Velez1 insp.
Rebecca Rodriguez1 insp.
Ramon A Hernandez1 insp.
Laura E Garcia1 insp.
Brenda Rivera1 insp.
Jose A Lopez Rubet1 insp.
Pablo Feliciano1 insp.
Miguel A Martinez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbvie LTD's 8 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