Atlas

Form 483

Fareva Richmond, Inc. Form 483, 2015-02-20

FDA issued a Form 483 to Fareva Richmond, Inc. on 2015-02-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Fareva Richmond, Inc. · Henrico, United States · Issued February 20, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 Feb 2015
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by James M Simpson, Jonathan W Chapman

20 Feb 2015
21 CFR 211.25(a)

GMP Training Frequency

Cited by James M Simpson, Jonathan W Chapman

Inspected site

FRFareva Richmond, Inc.Henrico, United States

Inspection team

JMJames M Simpson
JWJonathan W Chapman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(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