Form 483

Bleu Ribbon Delicacies, LLC dba Native Cure Form 483, 2016-12-19

FDA issued a Form 483 to Bleu Ribbon Delicacies, LLC dba Native Cure on 2016-12-19 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Bleu Ribbon Delicacies, LLC dba Native Cure · North Hollywood, United States · Issued December 19, 2016

Overview

  • 10 public-safe observations are available for this inspection.
  • 8 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.

19 Dec 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Jeffrey P Raimondi, Rocio Guzman-Velazquez, Darrin E Davis

19 Dec 2016
21 CFR 123.12(a)(2)

Importer verification

Cited by Jeffrey P Raimondi, Rocio Guzman-Velazquez, Darrin E Davis

19 Dec 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Jeffrey P Raimondi, Rocio Guzman-Velazquez, Darrin E Davis

19 Dec 2016
21 CFR 123.6(b)

HACCP plan location

Cited by Jeffrey P Raimondi, Rocio Guzman-Velazquez, Darrin E Davis

19 Dec 2016
21 CFR 123.6(b)

No HACCP plan

Cited by Jeffrey P Raimondi, Rocio Guzman-Velazquez, Darrin E Davis

Inspected site

BRBleu Ribbon Delicacies, LLC dba Native CureNorth Hollywood, 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 observations3x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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