Form 483

Westwood Laboratories, LLC. Form 483, 2015-02-25

FDA issued a Form 483 to Westwood Laboratories, LLC. on 2015-02-25 with 10 public-safe observations.

483· Form 483 issuedHuman Drugs10 observations

Westwood Laboratories, LLC. · Azusa, United States · Issued February 25, 2015

Overview

  • 10 public-safe observations are available for this inspection.
  • 9 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.

25 Feb 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Carla J Lundi

25 Feb 2015
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Carla J Lundi

25 Feb 2015
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Carla J Lundi

25 Feb 2015
21 CFR 211.165(a)

Testing and release for distribution

Cited by Carla J Lundi

25 Feb 2015
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Carla J Lundi

Inspected site

WLWestwood Laboratories, LLC.Azusa, 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 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited 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
21 CFR 211.25(a)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 10 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