Atlas

Form 483

Pharmacia Hepar LLC Form 483, 2010-05-25

FDA issued a Form 483 to Pharmacia Hepar LLC on 2010-05-25 with 3 public-safe observations.

483· Form 483 issued3 observations

Pharmacia Hepar LLC · Franklin, United States · Issued May 25, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

25 May 2010
21 CFR 211.63

Equipment Design, Size and Location

Cited by Michael P Sheehan

25 May 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Michael P Sheehan

25 May 2010
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Michael P Sheehan

Inspected site

PHPharmacia Hepar LLCFranklin, United States

Inspection team

MPMichael P Sheehan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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