Form 483

Westwood Laboratories, LLC. Form 483, 2022-04-05

FDA issued a Form 483 to Westwood Laboratories, LLC. on 2022-04-05 with 12 public-safe observations.

483· Form 483 issuedHuman Drugs12 observations

Westwood Laboratories, LLC. · Azusa, United States · Issued April 5, 2022

Overview

  • 12 public-safe observations are available for this inspection.
  • 4 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.

5 Apr 2022
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Alan L Truong

5 Apr 2022
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Alan L Truong

5 Apr 2022
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Alan L Truong

5 Apr 2022
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Alan L Truong

5 Apr 2022
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Alan L Truong

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 observations3x
21 CFR 211.113(a)Cited across public-safe Form 483 observations3x
21 CFR 211.188Cited across public-safe Form 483 observations3x
21 CFR 211.68(b)Cited across public-safe Form 483 observations3x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 12 observations

The source PDF, 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