Form 483

Regalo's Favorite of Hawaii Inc. Form 483, 2011-12-08

FDA issued a Form 483 to Regalo's Favorite of Hawaii Inc. on 2011-12-08 with 4 public-safe observations.

483· Form 483 issued4 observations

Regalo's Favorite of Hawaii Inc. · Honolulu, United States · Issued December 8, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

8 Dec 2011
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Craig K Hopkins

8 Dec 2011
21 CFR 110.10(b)(6)

Failure to wear

Cited by Craig K Hopkins

8 Dec 2011
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Craig K Hopkins

8 Dec 2011
21 CFR 110.40(a)

Food-contact - withstand food & cleaning cmpds.

Cited by Craig K Hopkins

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 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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