Atlas

Form 483

IndeCon, Inc. Form 483, 2014-05-29

FDA issued a Form 483 to IndeCon, Inc. on 2014-05-29 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

IndeCon, Inc. · Dallas, United States · Issued May 29, 2014

Overview

  • 3 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.

29 May 2014
21 CFR 1271.260(e)

Storage temperatures recorded, maintained

Cited by Young M Yoon

29 May 2014
21 CFR 1271.265(e)

Documentation elements for activities

Cited by Young M Yoon

29 May 2014
21 CFR 1271.265(e)

Procedures and release criteria

Cited by Young M Yoon

Inspected site

IIIndeCon, Inc.Dallas, United States

Inspection team

YMYoung M Yoon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.265(e)Cited across public-safe Form 483 observations2x
21 CFR 1271.260(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

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