Atlas

FDA-Inspected Site

Akers Biosciences, Inc.

6 FDA inspections are on record for Akers Biosciences, Inc. in Thorofare, United States.

Clean· No action indicated

Thorofare, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2015-11-04.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Nov 2015 – 4 Nov 2015Medical Devices & Rad HealthClean
11 Apr 2012Not recorded483View 483 →
9 May 2011Not recordedWLView 483 →
9 Apr 2009Not recorded483View 483 →
28 Apr 2004Not recordedClean
14 Aug 2001Not recordedClean

Observations on record

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

11 Apr 2012
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Loretta Nemchik

11 Apr 2012
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Loretta Nemchik

11 Apr 2012
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Loretta Nemchik

11 Apr 2012
21 CFR 820.80(a)

Lack of or inadequate procedures - Acceptance activities

Cited by Loretta Nemchik

9 May 2011
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Loretta Nemchik, Meredith L Sheridan

Investigators

FDA investigators tied to this site in the record.

Loretta Nemchik3 insp.
Meredith L Sheridan2 insp.
Krystyna M Kitson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.70(i)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(a)Cited across public-safe Form 483 observations1x
21 CFR 820.90(b)(1)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Akers Biosciences, Inc.'s 3 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