Atlas

Form 483

Blispak, Inc. Form 483, 2014-10-09

FDA issued a Form 483 to Blispak, Inc. on 2014-10-09 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Blispak, Inc. · Whippany, United States · Issued October 9, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

9 Oct 2014
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Steven P Donald, Alberto A Viciedo

9 Oct 2014
21 CFR 211.130(e)

Packaging line inspection before use

Cited by Steven P Donald, Alberto A Viciedo

Inspected site

BIBlispak, Inc.Whippany, United States

Inspection team

SPSteven P Donald
AAAlberto A Viciedo

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 211.130(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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