Atlas

Form 483

Medical Center of the Rockies Form 483, 2014-01-16

FDA issued a Form 483 to Medical Center of the Rockies on 2014-01-16 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Medical Center of the Rockies · Loveland, United States · Issued January 16, 2014

Overview

  • 3 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.

16 Jan 2014
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Kathleen S Tormey

16 Jan 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Kathleen S Tormey

16 Jan 2014
21 CFR 606.160(a)(1)

Person performing, test results, interpretation

Cited by Kathleen S Tormey

Inspected site

MCMedical Center of the RockiesLoveland, United States

Inspection team

KSKathleen S Tormey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)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