Form 483

Custompax, Inc., dba Vitaganic Form 483, 2010-06-09

FDA issued a Form 483 to Custompax, Inc., dba Vitaganic on 2010-06-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Custompax, Inc., dba Vitaganic · Fremont, United States · Issued June 9, 2010

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 Jun 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Ronald P Boyce, Michael C Nausin

9 Jun 2010
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Ronald P Boyce, Michael C Nausin

Inspected site

CICustompax, Inc., dba VitaganicFremont, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)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