Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-17.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 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.
9 Aug 2019
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Marinee Flores-Marrero
9 Aug 2019
21 CFR 111.35(b)(4)
Records - equipment; calibrations, inspections, checks
Cited by Marinee Flores-Marrero
9 Aug 2019
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Marinee Flores-Marrero
Investigators
FDA investigators tied to this site in the record.
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 111.35(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 111.205(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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | 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 4 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