Atlas

Form 483

Conopco, Inc. d/b/a Unilever Form 483, 2016-09-16

FDA issued a Form 483 to Conopco, Inc. d/b/a Unilever on 2016-09-16 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Conopco, Inc. d/b/a Unilever · Raeford, United States · Issued September 16, 2016

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.

16 Sep 2016
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Sonya M Edmonds

16 Sep 2016
21 CFR 211.192

No written record of investigation

Cited by Sonya M Edmonds

16 Sep 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sonya M Edmonds

Inspected site

CIConopco, Inc. d/b/a UnileverRaeford, United States

Inspection team

SMSonya M Edmonds

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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