Atlas

FDA-Inspected Site

BioZone Laboratories, Inc.

4 FDA inspections are on record for BioZone Laboratories, Inc. in Pittsburg, United States.

483· Form 483 issued

Pittsburg, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2013-08-09.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Aug 2013 – 9 Aug 2013Human Drugs483View 483 →
29 Aug 2012Not recorded483View 483 →
31 Jan 2011Not recorded483On file
28 Apr 2009Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

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

29 Aug 2012
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by William V Millar

29 Aug 2012
21 CFR 211.100(a)

Absence of Written Procedures

Cited by William V Millar

Investigators

FDA investigators tied to this site in the record.

Rochelle B Young2 insp.
Stephanie A Slater1 insp.
Ashar P Parikh1 insp.
William V Millar1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.142(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.122(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BioZone Laboratories, Inc.'s 4 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat