Atlas

Form 483

Ducommun Labarge Technologies Form 483, 2017-08-11

FDA issued a Form 483 to Ducommun Labarge Technologies on 2017-08-11 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Ducommun Labarge Technologies · Appleton, United States · Issued August 11, 2017

Overview

  • 6 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.

11 Aug 2017
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Richard J Tucker

11 Aug 2017
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Richard J Tucker

11 Aug 2017
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Richard J Tucker

11 Aug 2017
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Richard J Tucker

11 Aug 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Richard J Tucker

Inspected site

DLDucommun Labarge TechnologiesAppleton, United States

Inspection team

RJRichard J Tucker

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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