Form 483

Blood Bank of Alaska, Inc. Form 483, 2012-03-28

FDA issued a Form 483 to Blood Bank of Alaska, Inc. on 2012-03-28 with 5 public-safe observations.

483· Form 483 issued5 observations

Blood Bank of Alaska, Inc. · Anchorage, United States · Issued March 28, 2012

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

28 Mar 2012
21 CFR 606.40(a)(1)

Provide space for examination

Cited by Alexander M Kay

28 Mar 2012
21 CFR 606.100(c)

Record review prior to release

Cited by Alexander M Kay

28 Mar 2012
21 CFR 606.100(c)

Thorough investigations

Cited by Alexander M Kay

28 Mar 2012
21 CFR 606.170(a)

Adverse Reaction - Investigations

Cited by Alexander M Kay

28 Mar 2012
21 CFR 630.40(b)(4)

Follow up and counseling

Cited by Alexander M Kay

Inspected site

BBBlood Bank of Alaska, Inc.Anchorage, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations2x
21 CFR 606.170(a)Cited across public-safe Form 483 observations1x
21 CFR 606.40(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 630.40(b)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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