Atlas

Form 483

Children's Hospital and Research Center at Oakland Form 483, 2013-01-09

FDA issued a Form 483 to Children's Hospital and Research Center at Oakland on 2013-01-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Children's Hospital and Research Center at Oakland · Oakland, United States · Issued January 9, 2013

Overview

  • 2 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.

9 Jan 2013
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Mary E Wilkerson-Brinsko

9 Jan 2013
21 CFR 606.60(b)

Equipment calibration frequency

Cited by Mary E Wilkerson-Brinsko

Inspected site

CHChildren's Hospital and Research Center at OaklandOakland, United States

Inspection team

MEMary E Wilkerson-Brinsko

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.60(a)Cited across public-safe Form 483 observations1x
21 CFR 606.60(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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