Atlas

Form 483

SunOpta Aseptic, Inc. Form 483, 2011-04-14

FDA issued a Form 483 to SunOpta Aseptic, Inc. on 2011-04-14 with 2 public-safe observations.

483· Form 483 issued2 observations

SunOpta Aseptic, Inc. · Heuvelton, United States · Issued April 14, 2011

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.

14 Apr 2011
21 CFR 110.20(a)(1)

Harborage areas

Cited by Wayne S Thompson, Charla L Glenister

14 Apr 2011
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Wayne S Thompson, Charla L Glenister

Inspected site

SASunOpta Aseptic, Inc.Heuvelton, United States

Inspection team

WSWayne S Thompson
CLCharla L Glenister

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)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