Atlas

Form 483

Children's Hospital and Research Center at Oakland Form 483, 2017-09-12

FDA issued a Form 483 to Children's Hospital and Research Center at Oakland on 2017-09-12 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Children's Hospital and Research Center at Oakland · Oakland, United States · Issued September 12, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

12 Sep 2017
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Seyyida Saterfield

Inspected site

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

Inspection team

SSSeyyida Saterfield

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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