Atlas

Form 483

St Agnes Healthcare Blood Bank Form 483, 2009-07-17

FDA issued a Form 483 to St Agnes Healthcare Blood Bank on 2009-07-17 with 2 public-safe observations.

483· Form 483 issued2 observations

St Agnes Healthcare Blood Bank · Baltimore, United States · Issued July 17, 2009

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.

17 Jul 2009
21 CFR 600.80(c)(2)(ii)

Reporting Requirement - Periodic adv. exp. report content

Cited by Joseph W Matthews

17 Jul 2009
21 CFR 606.100(b)

Written SOPs available for use by personnel

Cited by Joseph W Matthews

Inspected site

SASt Agnes Healthcare Blood BankBaltimore, United States

Inspection team

JWJoseph W Matthews

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 600.80(c)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)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