Form 483

American Health Packaging Form 483, 2012-09-10

FDA issued a Form 483 to American Health Packaging on 2012-09-10 with 2 public-safe observations.

483· Form 483 issued2 observations

American Health Packaging · Columbus, United States · Issued September 10, 2012

Overview

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

Inspectional observations

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

10 Sep 2012
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Dell S Moller

10 Sep 2012
21 CFR 211.80(d)

Status of Each Lot Identified

Cited by Dell S Moller

Inspected site

AHAmerican Health PackagingColumbus, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)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