Form 483

Jogue, Inc. Form 483, 2011-05-26

FDA issued a Form 483 to Jogue, Inc. on 2011-05-26 with 4 public-safe observations.

483· Form 483 issued4 observations

Jogue, Inc. · Ontario, United States · Issued May 26, 2011

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.

26 May 2011
21 CFR 120.6(b)

Sanitation monitoring

Cited by Dyana K Stone

26 May 2011
21 CFR 120.8(b)(4)

HACCP plan - monitoring procedures not adequate

Cited by Dyana K Stone

26 May 2011
21 CFR 120.11(a)(1)

Verification activities - minimum

Cited by Dyana K Stone

26 May 2011
21 CFR 120.11(a)(2)

Calibration, testing - no records

Cited by Dyana K Stone

Inspected site

JIJogue, Inc.Ontario, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(4)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