Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-21.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2023 – 21 Apr 2023 | Human Drugs | 483 | View 483 → |
| 2 Mar 2020 – 6 Mar 2020 | Human Drugs | Clean | |
| 15 Mar 2018 – 22 Mar 2018 | Human Drugs | Clean | |
| 4 Apr 2016 – 12 Apr 2016 | Human Drugs | 483 | View 483 → |
| 11 Jun 2015 – 19 Jun 2015 | Human Drugs | 483 | View 483 → |
| 20 Mar 2014 – 28 Mar 2014 | Human Drugs | WL | View 483 → |
| 29 Sep 2011 | Not recorded | 483 | On file |
| 24 Sep 2009 | Not recorded | Clean | |
| 8 Jun 2007 | Not recorded | Clean | |
| 31 Mar 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jose M Cayuela1 insp.
MRA DavisM1 insp.
Satheesh Thomas1 insp.
Ademola O Daramola1 insp.
Xiomara Copeland1 insp.
Nadeem I Chaudhry1 insp.
Michael E Maselli1 insp.
Robert M Barbosa1 insp.
Heika R Tait1 insp.
Justin A Boyd1 insp.
Katherine Szestypalow1 insp.
Gwyn G Dickinson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HIKMA FARMACEUTICA (PORTUGAL), S.A's 5 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