Atlas

Form 483

Akers Biosciences, Inc. Form 483, 2009-04-09

FDA issued a Form 483 to Akers Biosciences, Inc. on 2009-04-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Akers Biosciences, Inc. · Thorofare, United States · Issued April 9, 2009

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Apr 2009
21 CFR 820.100(a)(4)

CAPA verification/validation of corrective/preventive action

Cited by Loretta Nemchik, Krystyna M Kitson

9 Apr 2009
21 CFR 820.198(a)

General

Cited by Loretta Nemchik, Krystyna M Kitson

Inspected site

ABAkers Biosciences, Inc.Thorofare, United States

Inspection team

LNLoretta Nemchik
KMKrystyna M Kitson

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere