Atlas

Form 483

EPM Packaging, Inc. Form 483, 2010-02-04

FDA issued a Form 483 to EPM Packaging, Inc. on 2010-02-04 with 2 public-safe observations.

483· Form 483 issued2 observations

EPM Packaging, Inc. · Lexington, United States · Issued February 4, 2010

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.

4 Feb 2010
21 CFR 211.186(b)(9)

Manufacturing Instructions and Specifications

Cited by Eric M Mueller, Joseph R Lambert

4 Feb 2010
21 CFR 211.192

No written record of investigation

Cited by Eric M Mueller, Joseph R Lambert

Inspected site

EPEPM Packaging, Inc.Lexington, United States

Inspection team

EMEric M Mueller
JRJoseph R Lambert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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