FDA-Inspected Site

GRAM Laboratories, Inc.

10 FDA inspections are on record for GRAM Laboratories, Inc. in Irvine, United States.

483· Form 483 issued

Irvine, United States · Last updated August 15, 2026

Overview

  • 10 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-08.

At a glance

Inspections

10

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Apr 2025 – 8 Apr 2025Human Drugs483View 483 →
13 Sep 2018 – 19 Sep 2018Human DrugsClean
31 Aug 2015 – 4 Sep 2015Human Drugs483On file
30 Oct 2012Not recordedClean
13 Jul 2011Not recordedClean
16 Feb 2010Not recordedClean
10 Jun 2008Not recordedClean
7 Jul 2006Not recordedClean
31 Jul 2003Not recordedClean
4 Oct 2000Not recordedClean

Observations on record

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

8 Apr 2025
21 CFR 211.192

Written record of investigation incomplete

Cited by Wenzheng Zhang

8 Apr 2025
21 CFR 211.25(a)

GMP Training Frequency

Cited by Wenzheng Zhang

8 Apr 2025
21 CFR 211.63

Equipment Design, Size and Location

Cited by Wenzheng Zhang

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind GRAM Laboratories, Inc.'s 2 Form 483s

Source PDFs 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