FDA-Inspected Site

Medical Scientific Technologies LLC

10 FDA inspections are on record for Medical Scientific Technologies LLC in Union, United States.

483· Form 483 issued

Union, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-07.

At a glance

Inspections

10

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Feb 2025 – 7 Feb 2025Human Drugs483View 483 →
31 Aug 2015 – 4 Sep 2015Human Drugs483On file
28 Jan 2014 – 6 Feb 2014Human Drugs483View 483 →
20 Jan 2012Not recordedClean
17 Jun 2010Not recordedClean
18 Sep 2009Not recorded483View 483 →
29 Aug 2008Not recorded483On file
12 May 2006Not recordedClean
6 Aug 2004Not recordedClean
7 Dec 2001Not recordedClean

Observations on record

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

7 Feb 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jared P Stevens

6 Feb 2014
21 CFR 211.68(b)

Backup file not maintained

Cited by Bonita S Chester

6 Feb 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Bonita S Chester

18 Sep 2009
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Tracy R Ball, Thomas R Berry

18 Sep 2009
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Tracy R Ball, Thomas R Berry

Investigators

FDA investigators tied to this site in the record.

Penny H Mccarver2 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Medical Scientific Technologies LLC's 5 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