Atlas

Form 483

Interstate Blood Bank, Inc of Wisconsin Form 483, 2021-08-02

FDA issued a Form 483 to Interstate Blood Bank, Inc of Wisconsin on 2021-08-02 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

Interstate Blood Bank, Inc of Wisconsin · Madison, United States · Issued August 2, 2021

Overview

  • 4 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.

2 Aug 2021
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Susan M North

2 Aug 2021
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Susan M North

2 Aug 2021
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Susan M North

2 Aug 2021
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Susan M North

Inspected site

IBInterstate Blood Bank, Inc of WisconsinMadison, United States

Inspection team

SMSusan M North

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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