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Form 483

Quality Chemical Laboratories Form 483, 2017-07-27

FDA issued a Form 483 to Quality Chemical Laboratories on 2017-07-27 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Quality Chemical Laboratories · Wilmington, United States · Issued July 27, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Jul 2017
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Kara D Dobbin, Tajah L Blackburn

27 Jul 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kara D Dobbin, Tajah L Blackburn

Inspected site

QCQuality Chemical LaboratoriesWilmington, United States

Inspection team

KDKara D Dobbin
TLTajah L Blackburn

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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.

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Full 483 report

Get the verbatim text of all 2 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