Form 483

Regalo's Favorite of Hawaii Inc. Form 483, 2016-09-06

FDA issued a Form 483 to Regalo's Favorite of Hawaii Inc. on 2016-09-06 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Regalo's Favorite of Hawaii Inc. · Honolulu, United States · Issued September 6, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

6 Sep 2016
21 CFR 110.40(a)

Food-contact - unlawful indirect additives

Cited by Stuart Kim, Lisa K Capron

6 Sep 2016
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Stuart Kim, Lisa K Capron

6 Sep 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Stuart Kim, Lisa K Capron

6 Sep 2016
21 CFR 110.20(b)(7)

Screening

Cited by Stuart Kim, Lisa K Capron

6 Sep 2016
21 CFR 110.35(d)(3)

Non-food-contact surfaces (S)

Cited by Stuart Kim, Lisa K Capron

Inspected site

RFRegalo's Favorite of Hawaii Inc.Honolulu, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)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