Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-09.
At a glance
Inspections
6
Form 483s
3
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Jul 2023 – 9 Aug 2023 | Animal Drugs & Feeds | 483 | View 483 → |
| 6 Aug 2018 – 14 Aug 2018 | Animal Drugs & Feeds | 483 | On file |
| 15 Feb 2016 – 23 Feb 2016 | Animal Drugs & Feeds | Clean | |
| 11 Dec 2012 | Not recorded | 483 | View 483 → |
| 10 Jun 2010 | Not recorded | Clean | |
| 25 Aug 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Aug 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Marian E Ramirez, Damaris Y Hernandez
9 Aug 2023
21 CFR 211.198(a)
Complaints reviewed by Quality Control Unit
Cited by Marian E Ramirez, Damaris Y Hernandez
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez2 insp.
Marian E Ramirez1 insp.
Damaris Y Hernandez1 insp.
Rafael Nevarez Nieves1 insp.
Ramon A Hernandez1 insp.
Iraida Ortiz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Unio Qumica Farmacutica Nacional SA's 3 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