FDA-Inspected Site

Grato Holdings, Inc.

15 FDA inspections are on record for Grato Holdings, Inc. in Woodbine, United States.

483· Form 483 issued

Woodbine, United States · Last updated July 10, 2026

Overview

  • 15 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-16.

At a glance

Inspections

15

Form 483s

9

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Apr 2026 – 16 Apr 2026Human Drugs483On file
2 Feb 2026 – 3 Feb 2026Foods & CosmeticsClean
15 Sep 2025 – 19 Sep 2025Human Drugs483View 483 →
27 Jun 2022 – 14 Jul 2022Human Drugs483On file
7 Jul 2021 – 14 Jul 2021Human Drugs483View 483 →
2 Dec 2019 – 6 Dec 2019Human Drugs483View 483 →
26 Feb 2018 – 2 Mar 2018Human Drugs483On file
9 Feb 2015 – 27 Feb 2015Human Drugs483View 483 →
6 Jun 2013 – 19 Jun 2013Human DrugsClean
20 Apr 2011Not recordedClean
25 Mar 2011Not recorded483View 483 →
28 Oct 2009Not recordedClean

Observations on record

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

19 Sep 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Tyler M Peterson

14 Jul 2021
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Wayne D Mcgrath, Lisa L Flores

14 Jul 2021
21 CFR 211.165(b)

Microbiological testing

Cited by Wayne D Mcgrath, Lisa L Flores

14 Jul 2021
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Wayne D Mcgrath, Lisa L Flores

14 Jul 2021
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Wayne D Mcgrath, Lisa L Flores

Investigators

FDA investigators tied to this site in the record.

State Agency2 insp.
David L Miser1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(e)Cited across public-safe Form 483 observations2x
21 CFR 211.186(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(c)Cited across public-safe Form 483 observations2x
21 CFR 211.80(a)Cited across public-safe Form 483 observations2x
21 CFR 111.140(b)(3)(vii)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(f)Cited across public-safe Form 483 observations1x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.84(e)Cited across public-safe Form 483 observations1x
21 CFR 211.89Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Grato Holdings, Inc.'s 9 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