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Form 483

Banco De Sangre Humacao, Inc. Form 483, 2022-07-21

FDA issued a Form 483 to Banco De Sangre Humacao, Inc. on 2022-07-21 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Banco De Sangre Humacao, Inc. · Humacao, United States · Issued July 21, 2022

Overview

  • 3 public-safe observations are 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.

21 Jul 2022
21 CFR 630.10(g)(1)

Proof Of Identity

Cited by Annette Melendez

21 Jul 2022
21 CFR 630.10(g)(1)

Proof Of Identity

Cited by Annette Melendez

21 Jul 2022
21 CFR 630.10(g)(1)

Proof Of Identity

Cited by Annette Melendez

Inspected site

BDBanco De Sangre Humacao, Inc.Humacao, United States

Inspection team

AMAnnette Melendez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 630.10(g)(1)Cited across public-safe Form 483 observations3x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, 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