Atlas

Form 483

Fougera Pharmaceuticals, LLC Form 483, 2013-10-31

FDA issued a Form 483 to Fougera Pharmaceuticals, LLC on 2013-10-31 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Fougera Pharmaceuticals, LLC · Melville, United States · Issued October 31, 2013

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.

31 Oct 2013
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Paul C Mouris

31 Oct 2013
21 CFR 211.110(a)

Written in-process control procedures

Cited by Paul C Mouris

Inspected site

FPFougera Pharmaceuticals, LLCMelville, United States

Inspection team

PCPaul C Mouris

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 211.67(a)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