Atlas

Form 483

American Regent, Inc. Form 483, 2009-11-05

FDA issued a Form 483 to American Regent, Inc. on 2009-11-05 with 2 public-safe observations.

483· Form 483 issued2 observations

American Regent, Inc. · Shirley, United States · Issued November 5, 2009

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.

5 Nov 2009
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Paul C Mouris

5 Nov 2009
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Paul C Mouris

Inspected site

ARAmerican Regent, Inc.Shirley, United States

Inspection team

PCPaul C Mouris

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.170(b)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