Form 483

Chemolee Lab Corporation Form 483, 2013-07-18

FDA issued a Form 483 to Chemolee Lab Corporation on 2013-07-18 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Chemolee Lab Corporation · Irving, United States · Issued July 18, 2013

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

18 Jul 2013
21 CFR 211.22(a)

Approve or reject components, products

Cited by Charles D Brown

18 Jul 2013
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Charles D Brown

18 Jul 2013
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Charles D Brown

18 Jul 2013
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Charles D Brown

18 Jul 2013
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Charles D Brown

Inspected site

CLChemolee Lab CorporationIrving, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(12)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

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