Atlas

Form 483

Banco De Sangre Humacao, Inc. Form 483, 2013-07-03

FDA issued a Form 483 to Banco De Sangre Humacao, Inc. on 2013-07-03 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Banco De Sangre Humacao, Inc. · Humacao, United States · Issued July 3, 2013

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.

3 Jul 2013
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Annette Melendez

3 Jul 2013
21 CFR 606.160(a)(1)

Person performing, test results, interpretation

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 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)Cited 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