Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-29.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2026 – 29 Jun 2026 | Foods & Cosmetics | 483 | View 483 → |
| 13 Feb 2023 – 17 Feb 2023 | Human Drugs | WL | On file |
| 5 Aug 2019 – 9 Aug 2019 | Foods & Cosmetics | 483 | View 483 → |
| 26 Jan 2016 – 28 Apr 2016 | Human Drugs | 483 | View 483 → |
| 23 Jan 2013 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jun 2026
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Lissette Paiz, Manuel F Uribe, Zuleima Y Chow
29 Jun 2026
21 CFR 111.20(c)
Physical plant - prevent mix-ups, contamination
Cited by Lissette Paiz, Manuel F Uribe, Zuleima Y Chow
29 Jun 2026
21 CFR 111.260
Batch record - required information
Cited by Lissette Paiz, Manuel F Uribe, Zuleima Y Chow
29 Jun 2026
21 CFR 111.27(d)
Equipment - maintain - general
Cited by Lissette Paiz, Manuel F Uribe, Zuleima Y Chow
29 Jun 2026
21 CFR 111.30(c)
Equipment - automated - calibrate, inspect
Cited by Lissette Paiz, Manuel F Uribe, Zuleima Y Chow
Investigators
FDA investigators tied to this site in the record.
Lissette Paiz1 insp.
Manuel F Uribe1 insp.
Zuleima Y Chow1 insp.
Steven A Brettler1 insp.
Marinee Flores-Marrero1 insp.
Jennifer Lalama1 insp.
Ileana Barreto-Pettit1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.37 | 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 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gadal Laboratories Inc.'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