Form 483

Diamond Wipes International, Inc. Form 483, 2015-11-02

FDA issued a Form 483 to Diamond Wipes International, Inc. on 2015-11-02 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

Diamond Wipes International, Inc. · Chino, United States · Issued November 2, 2015

Overview

  • 8 public-safe observations are available for this inspection.
  • 6 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.

2 Nov 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Marcus F Yambot

2 Nov 2015
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Marcus F Yambot

2 Nov 2015
21 CFR 211.130(c)

Lot or control number assigned

Cited by Marcus F Yambot

2 Nov 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Marcus F Yambot

2 Nov 2015
21 CFR 211.165(a)

Testing and release for distribution

Cited by Marcus F Yambot

Inspected site

DWDiamond Wipes International, Inc.Chino, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.130(c)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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