FDA-Inspected Site

EMS Acquisition Corp

6 FDA inspections are on record for EMS Acquisition Corp in Morgantown, United States.

483· Form 483 issued

Morgantown, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-24.

At a glance

Inspections

6

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Oct 2025 – 24 Oct 2025Human Drugs483View 483 →
18 Jul 2022 – 22 Jul 2022Human Drugs483View 483 →
20 Oct 2015 – 22 Oct 2015Human Drugs483View 483 →
10 Jan 2013Not recordedClean
6 Nov 2008Not recorded483View 483 →
15 Mar 2007Not recordedClean

Observations on record

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

24 Oct 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Azeezat M Lawal

24 Oct 2025
21 CFR 211.165(b)

Microbiological testing

Cited by Azeezat M Lawal

24 Oct 2025
21 CFR 211.68(b)

Computer control of master formula records

Cited by Azeezat M Lawal

24 Oct 2025
21 CFR 211.84(d)(2)

Component identification test

Cited by Azeezat M Lawal

22 Jul 2022
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Christina K Theodorou, Elaine E Gilfillan

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 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind EMS Acquisition Corp'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