Atlas

Form 483

XGen Pharmaceuticals DJB, Inc. Form 483, 2012-03-08

FDA issued a Form 483 to XGen Pharmaceuticals DJB, Inc. on 2012-03-08 with 4 public-safe observations.

483· Form 483 issued4 observations

XGen Pharmaceuticals DJB, Inc. · Horseheads, United States · Issued March 8, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

8 Mar 2012
21 CFR 211.25(a)

GMP Training Frequency

Cited by Chad N Thompson

8 Mar 2012
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Chad N Thompson

8 Mar 2012
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Chad N Thompson

8 Mar 2012
21 CFR 314.81(b)(2)

Timely submission

Cited by Chad N Thompson

Inspected site

XPXGen Pharmaceuticals DJB, Inc.Horseheads, United States

Inspection team

CNChad N Thompson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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