Overview
- 19 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
19
Form 483s
12
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2026 – 5 Feb 2026 | Biologics | 483 | View 483 → |
| 9 Sep 2024 – 18 Sep 2024 | Biologics | 483 | On file |
| 12 Sep 2022 – 24 Sep 2022 | Biologics | 483 | On file |
| 8 Sep 2021 – 24 Sep 2021 | Human Drugs | 483 | On file |
| 16 Sep 2019 – 26 Sep 2019 | Biologics | WL | On file |
| 1 Aug 2017 – 22 Aug 2017 | Medical Devices & Rad Health | 483 | On file |
| 18 Mar 2015 – 25 Mar 2015 | Medical Devices & Rad Health | 483 | On file |
| 12 Feb 2014 – 21 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 9 Apr 2013 – 25 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
| 24 Feb 2012 | Not recorded | 483 | On file |
| 23 Mar 2010 | Not recorded | 483 | On file |
| 2 Feb 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.180(e)(1)
Representative Number of Batches for Annual Review
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
Investigators
FDA investigators tied to this site in the record.
Noreen Muniz4 insp.
Scott T Ballard3 insp.
Laura E Garcia3 insp.
Jose A Cruz Gonzalez2 insp.
Ramon L Gonzalez-Prieto1 insp.
Cody D Rickman1 insp.
Lizaida Perez1 insp.
Annette Melendez1 insp.
Randy L Clarida1 insp.
Nimmy Mathews1 insp.
Laurimer Kuilan-Torres1 insp.
Cassandra L Abellard1 insp.
Laiza V Garcia1 insp.
Pablo Feliciano1 insp.
Jose A Moreno1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | 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 |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fenwal International, Inc.'s 12 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