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Form 483

Suncoast Communities Blood Bank, Inc. Form 483, 2022-07-01

FDA issued a Form 483 to Suncoast Communities Blood Bank, Inc. on 2022-07-01 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Suncoast Communities Blood Bank, Inc. · Bradenton, United States · Issued July 1, 2022

Overview

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

Inspectional observations

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

1 Jul 2022
21 CFR 606.100(c)

Thorough investigations

Cited by Barbara T Carmichael, Lura D Baquero, Edward A Brunt

Inspected site

SCSuncoast Communities Blood Bank, Inc.Bradenton, United States

Inspection team

BTBarbara T Carmichael
LDLura D Baquero
EAEdward A Brunt

Cited regulations

CFR citations associated with this Form 483.

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

Source document

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Form 483 source document

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Full 483 report

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  • 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