Overview
- 12 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-10.
At a glance
Inspections
12
Form 483s
10
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2026 – 10 Jun 2026 | Human Drugs | 483 | View 483 → |
| 17 Oct 2023 – 30 Oct 2023 | Human Drugs | 483 | On file |
| 12 Mar 2019 – 25 Mar 2019 | Human Drugs | 483 | View 483 → |
| 21 May 2018 – 1 Jun 2018 | Human Drugs | 483 | On file |
| 19 Apr 2017 – 28 Apr 2017 | Human Drugs | 483 | On file |
| 9 Jan 2017 – 13 Jan 2017 | Human Drugs | Clean | |
| 14 Mar 2016 – 24 Mar 2016 | Human Drugs | 483 | On file |
| 1 Jul 2014 – 16 Jul 2014 | Human Drugs | 483 | On file |
| 12 Jul 2012 | Not recorded | 483 | On file |
| 20 Sep 2011 | Not recorded | 483 | On file |
| 29 Apr 2011 | Not recorded | 483 | On file |
| 4 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jun 2026
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Marian E Ramirez, Mabany Lizardi, Christian F Gomez Lugo
10 Jun 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Marian E Ramirez, Mabany Lizardi, Christian F Gomez Lugo
10 Jun 2026
21 CFR 211.194(a)
Complete test data included in records
Cited by Marian E Ramirez, Mabany Lizardi, Christian F Gomez Lugo
25 Mar 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Libia M Lugo
25 Mar 2019
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Libia M Lugo
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo3 insp.
Noreen Muniz3 insp.
Jose A Cruz Gonzalez2 insp.
Marian E Ramirez1 insp.
Mabany Lizardi1 insp.
Christian F Gomez Lugo1 insp.
Jose E Melendez1 insp.
Thuy T Nguyen1 insp.
Ivis L Negron Torres1 insp.
Bo Chi1 insp.
Sharon K Thoma1 insp.
Raquel Gonzalez Rivera1 insp.
Rebecca Rodriguez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbvie Biotechnology Ltd.'s 10 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