Atlas

Form 483

Quality Chemical Laboratories Form 483, 2013-09-26

FDA issued a Form 483 to Quality Chemical Laboratories on 2013-09-26 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Quality Chemical Laboratories · Wilmington, United States · Issued September 26, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 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.

26 Sep 2013
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Viviana Matta

26 Sep 2013
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Viviana Matta

26 Sep 2013
21 CFR 211.165(e)

Test methods

Cited by Viviana Matta

Inspected site

QCQuality Chemical LaboratoriesWilmington, United States

Inspection team

VMViviana Matta

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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