Form 483

Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc. Form 483, 2013-12-16

FDA issued a Form 483 to Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc. on 2013-12-16 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc. · Carson, United States · Issued December 16, 2013

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

16 Dec 2013
21 CFR 110.20(a)(3)

Drainage

Cited by Eileen T Dupont, Celena Ngo, Tammy Vasquez Hancock

16 Dec 2013
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Eileen T Dupont, Celena Ngo, Tammy Vasquez Hancock

16 Dec 2013
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Eileen T Dupont, Celena Ngo, Tammy Vasquez Hancock

16 Dec 2013
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Eileen T Dupont, Celena Ngo, Tammy Vasquez Hancock

16 Dec 2013
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Eileen T Dupont, Celena Ngo, Tammy Vasquez Hancock

Inspected site

Inspection team

TVTammy Vasquez Hancock

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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