Atlas

FDA-Inspected Site

GADAL Laboratories, Inc

4 FDA inspections are on record for GADAL Laboratories, Inc in Miami, United States.

483· Form 483 issued

Miami, United States · Last updated July 10, 2026

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.

InspectionCategoryOutcomeForm 483
13 Feb 2023 – 17 Feb 2023Human DrugsWLOn file
5 Aug 2019 – 9 Aug 2019Foods & Cosmetics483View 483 →
26 Jan 2016 – 28 Apr 2016Human Drugs483View 483 →
23 Jan 2013Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

9 Aug 2019
21 CFR 111.27(d)

Equipment - maintain, clean, sanitize

Cited by Marinee Flores-Marrero

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

9 Aug 2019
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

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.

CitationWhat it coversCited
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations4x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations3x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.35(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.25(a)Cited across public-safe Form 483 observations1x
21 CFR 111.25(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260(d)Cited across public-safe Form 483 observations1x
21 CFR 111.27(d)Cited across public-safe Form 483 observations1x
21 CFR 111.30(b)Cited across public-safe Form 483 observations1x
21 CFR 111.315(d)Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

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