Atlas

Form 483

BioZone Laboratories, Inc. Form 483, 2013-08-09

FDA issued a Form 483 to BioZone Laboratories, Inc. on 2013-08-09 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

BioZone Laboratories, Inc. · Pittsburg, United States · Issued August 9, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Aug 2013
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Stephanie A Slater, Ashar P Parikh

9 Aug 2013
21 CFR 211.111

Establishment of time limitations

Cited by Stephanie A Slater, Ashar P Parikh

9 Aug 2013
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Stephanie A Slater, Ashar P Parikh

Inspected site

BLBioZone Laboratories, Inc.Pittsburg, United States

Inspection team

SAStephanie A Slater
APAshar P Parikh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)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