Atlas

Form 483

Banco de Sangre de Servicios Mutuos Inc.-Centro de Coleccion Bayamon Form 483, 2012-07-31

FDA issued a Form 483 to Banco de Sangre de Servicios Mutuos Inc.-Centro de Coleccion Bayamon on 2012-07-31 with 3 public-safe observations.

483· Form 483 issued3 observations

Banco de Sangre de Servicios Mutuos Inc.-Centro de Coleccion Bayamon · Bayamon, United States · Issued July 31, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

31 Jul 2012
21 CFR 211.100(a)

Approval and review of procedures

Cited by Juan R Jimenez Garcia

31 Jul 2012
21 CFR 606.100(b)(3)

Preparation of phlebotomy site

Cited by Juan R Jimenez Garcia

31 Jul 2012
21 CFR 606.100(b)(21)

Donor notification

Cited by Juan R Jimenez Garcia

Inspected site

BDBanco de Sangre de Servicios Mutuos Inc.-Centro de Coleccion BayamonBayamon, United States

Inspection team

JRJuan R Jimenez Garcia

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)(21)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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