Atlas

Form 483

Katena Products, Inc. Form 483, 2009-11-09

FDA issued a Form 483 to Katena Products, Inc. on 2009-11-09 with 1 public-safe observation.

483· Form 483 issued1 observation

Katena Products, Inc. · Randolph, United States · Issued November 9, 2009

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.

9 Nov 2009
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Charles Chacko

Inspected site

KPKatena Products, Inc.Randolph, United States

Inspection team

CCCharles Chacko

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50Cited 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