Atlas

Form 483

Indiana Blood Center Form 483, 2011-12-27

FDA issued a Form 483 to Indiana Blood Center on 2011-12-27 with 1 public-safe observation.

483· Form 483 issued1 observation

Indiana Blood Center · Muncie, United States · Issued December 27, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Dec 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Brandi N Mcgrady

Inspected site

IBIndiana Blood CenterMuncie, United States

Inspection team

BNBrandi N Mcgrady

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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