Form 483

Cedarlane Natural Foods North, Inc. Form 483, 2010-11-09

FDA issued a Form 483 to Cedarlane Natural Foods North, Inc. on 2010-11-09 with 11 public-safe observations.

483· Form 483 issued11 observations

Cedarlane Natural Foods North, Inc. · South San Francisco, United States · Issued November 9, 2010

Overview

  • 11 public-safe observations are available for this inspection.
  • 10 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 Nov 2010
21 CFR 110.35(a)

Buildings/good repair

Cited by Quynh Strandberg, Melody M Ragasa Leong

9 Nov 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by Quynh Strandberg, Melody M Ragasa Leong

9 Nov 2010
21 CFR 123.6(b)

No HACCP plan

Cited by Quynh Strandberg, Melody M Ragasa Leong

9 Nov 2010
21 CFR 123.6(c)(3)

Critical limits

Cited by Quynh Strandberg, Melody M Ragasa Leong

9 Nov 2010
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Quynh Strandberg, Melody M Ragasa Leong

Inspected site

CNCedarlane Natural Foods North, Inc.South San Francisco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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