Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-28.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2023 – 28 Jul 2023 | Animal Drugs & Feeds | 483 | View 483 → |
| 20 Mar 2017 – 28 Mar 2017 | Animal Drugs & Feeds | Clean | |
| 29 Jan 2015 – 6 Feb 2015 | Animal Drugs & Feeds | Clean | |
| 18 Oct 2012 | Not recorded | 483 | View 483 → |
| 17 Mar 2009 | Not recorded | 483 | On file |
| 26 May 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jul 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Laura S Huffman, Jacob G Lutz
28 Jul 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Laura S Huffman, Jacob G Lutz
28 Jul 2023
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Laura S Huffman, Jacob G Lutz
18 Oct 2012
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Russell J Glapion, Andrew J Idzior
Investigators
FDA investigators tied to this site in the record.
Laura S Huffman1 insp.
Jacob G Lutz1 insp.
Azza Talaat1 insp.
German Rivera1 insp.
Russell J Glapion1 insp.
Andrew J Idzior1 insp.
Brian D Nicholson1 insp.
Steven M Weinman1 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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Zoetis Manufacturing & Research Spain, S.L.'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