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Form 483

Blood Bank of Alaska, Inc. Form 483, 2019-03-22

FDA issued a Form 483 to Blood Bank of Alaska, Inc. on 2019-03-22 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Blood Bank of Alaska, Inc. · Anchorage, United States · Issued March 22, 2019

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.

22 Mar 2019
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Marc A Jackson

22 Mar 2019
21 CFR 640.11(a)

General requirements - storage

Cited by Marc A Jackson

Inspected site

BBBlood Bank of Alaska, Inc.Anchorage, United States

Inspection team

MAMarc A Jackson

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 640.11(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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