Atlas

Form 483

Suncoast Communities Blood Bank, Inc. Form 483, 2012-04-05

FDA issued a Form 483 to Suncoast Communities Blood Bank, Inc. on 2012-04-05 with 2 public-safe observations.

483· Form 483 issued2 observations

Suncoast Communities Blood Bank, Inc. · Bradenton, United States · Issued April 5, 2012

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.

5 Apr 2012
21 CFR 606.40

Clean & orderly

Cited by Mizanne E Lewis

5 Apr 2012
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Mizanne E Lewis

Inspected site

SCSuncoast Communities Blood Bank, Inc.Bradenton, United States

Inspection team

MEMizanne E Lewis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.40Cited 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