Atlas

FDA-Inspected Site

Geritrex Corp

11 FDA inspections are on record for Geritrex Corp in Mount Vernon, United States.

Clean· No action indicated

Mount Vernon, United States · Last updated August 15, 2026

Overview

  • 11 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-04-18.

At a glance

Inspections

11

Form 483s

6

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Apr 2018 – 18 Apr 2018Human DrugsClean
29 Jan 2018 – 2 Feb 2018Human Drugs483View 483 →
1 Oct 2015 – 19 Oct 2015Human Drugs483On file
13 Mar 2014 – 21 Mar 2014Human Drugs483On file
7 Feb 2011Not recorded483View 483 →
14 Dec 2009Not recorded483View 483 →
11 Jul 2008Not recorded483On file
30 Aug 2007Not recordedClean
7 Feb 2006Not recordedClean
9 Feb 2004Not recordedClean
18 Sep 2002Not recordedClean

Observations on record

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

2 Feb 2018
21 CFR 211.110(c)

In-process materials characteristics testing

Cited by Zhongren Wu

2 Feb 2018
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Zhongren Wu

2 Feb 2018
21 CFR 211.125(c)

Label reconciliation discrepancies evaluation/investigation

Cited by Zhongren Wu

2 Feb 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Zhongren Wu

2 Feb 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Zhongren Wu

Investigators

FDA investigators tied to this site in the record.

Demitria J Xiradakis2 insp.
Karen L Kosar1 insp.
Zhongren Wu1 insp.
Satheesh Thomas1 insp.
Sony Mathews1 insp.
Simone E Pitts1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 11Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.115(b)Cited across public-safe Form 483 observations1x
21 CFR 211.122(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(c)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
21 CFR 211.94(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Geritrex Corp's 6 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