Atlas

Form 483

Tacoma-Pierce County Blood Bank Form 483, 2011-09-20

FDA issued a Form 483 to Tacoma-Pierce County Blood Bank on 2011-09-20 with 1 public-safe observation.

483· Form 483 issued1 observation

Tacoma-Pierce County Blood Bank · Tacoma, United States · Issued September 20, 2011

Overview

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

Inspectional observations

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

20 Sep 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Kathryn A Krentz, Cynthia L Gorveatt

Inspected site

TCTacoma-Pierce County Blood BankTacoma, United States

Inspection team

KAKathryn A Krentz
CLCynthia L Gorveatt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)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