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Form 483

Suncoast Communities Blood Bank, Inc Form 483, 2022-04-13

FDA issued a Form 483 to Suncoast Communities Blood Bank, Inc on 2022-04-13 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Suncoast Communities Blood Bank, Inc · Sarasota, United States · Issued April 13, 2022

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.

13 Apr 2022
21 CFR 640.4(f)

Arm preparation

Cited by Amanda B Vega

Inspected site

SCSuncoast Communities Blood Bank, IncSarasota, United States

Inspection team

ABAmanda B Vega

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 640.4(f)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