Form 483

Fareva Richmond, Inc. Form 483, 2011-06-21

FDA issued a Form 483 to Fareva Richmond, Inc. on 2011-06-21 with 4 public-safe observations.

483· Form 483 issued4 observations

Fareva Richmond, Inc. · Henrico, United States · Issued June 21, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

21 Jun 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Brooke K Higgins

21 Jun 2011
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Brooke K Higgins

21 Jun 2011
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Brooke K Higgins

21 Jun 2011
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Brooke K Higgins

Inspected site

FRFareva Richmond, Inc.Henrico, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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