Atlas

Form 483

Zablocki, Clement J., Veterans Affairs Medical Center Form 483, 2010-03-26

FDA issued a Form 483 to Zablocki, Clement J., Veterans Affairs Medical Center on 2010-03-26 with 1 public-safe observation.

483· Form 483 issued1 observation

Zablocki, Clement J., Veterans Affairs Medical Center · Milwaukee, United States · Issued March 26, 2010

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.

26 Mar 2010
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Melissa J Holz

Inspected site

ZCZablocki, Clement J., Veterans Affairs Medical CenterMilwaukee, United States

Inspection team

MJMelissa J Holz

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