Atlas

Form 483

Troy Manufacturing, Inc. Form 483, 2013-02-12

FDA issued a Form 483 to Troy Manufacturing, Inc. on 2013-02-12 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Troy Manufacturing, Inc. · Hazle Township, United States · Issued February 12, 2013

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.

12 Feb 2013
21 CFR 211.67(b)

Written procedures not established/followed

Cited by James M Mason

12 Feb 2013
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by James M Mason

12 Feb 2013
21 CFR 211.111

Establishment of time limitations

Cited by James M Mason

Inspected site

TMTroy Manufacturing, Inc.Hazle Township, United States

Inspection team

JMJames M Mason

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited 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