Atlas

Form 483

CIMBAR PERFORMANCE MINERALS, INC. Form 483, 2017-02-03

FDA issued a Form 483 to CIMBAR PERFORMANCE MINERALS, INC. on 2017-02-03 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

CIMBAR PERFORMANCE MINERALS, INC. · Chatsworth, United States · Issued February 3, 2017

Overview

  • 4 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.

3 Feb 2017
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Larry K Hampton

3 Feb 2017
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Larry K Hampton

3 Feb 2017
21 CFR 212.20(d)

Determination need for investigation

Cited by Larry K Hampton

3 Feb 2017
21 CFR 606.100(c)

Thorough investigations

Cited by Larry K Hampton

Inspected site

CPCIMBAR PERFORMANCE MINERALS, INC.Chatsworth, United States

Inspection team

LKLarry K Hampton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 212.20(d)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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