Form 483

Diamond Wipes International, Inc. Form 483, 2017-05-17

FDA issued a Form 483 to Diamond Wipes International, Inc. on 2017-05-17 with 11 public-safe observations.

483· Form 483 issuedHuman Drugs11 observations

Diamond Wipes International, Inc. · Chino, United States · Issued May 17, 2017

Overview

  • 11 public-safe observations are available for this inspection.
  • 10 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.

17 May 2017
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Nicholas L Hunt

17 May 2017
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Nicholas L Hunt

17 May 2017
21 CFR 211.68(b)

Computer control of master formula records

Cited by Nicholas L Hunt

17 May 2017
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Nicholas L Hunt

17 May 2017
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nicholas L Hunt

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 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 11 observations

The source PDF and 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