Form 483

BB Riverboats Inc. - The Landing Form 483, 2016-07-11

FDA issued a Form 483 to BB Riverboats Inc. - The Landing on 2016-07-11 with 18 public-safe observations.

483· Form 483 issuedFoods & Cosmetics18 observations

BB Riverboats Inc. - The Landing · Newport, United States · Issued July 11, 2016

Overview

  • 18 public-safe observations are available for this inspection.
  • 15 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.

11 Jul 2016
21 CFR 110.10(b)(6)

Failure to wear

Cited by Andrew M Kupper, Ariel J Cutchins

11 Jul 2016
21 CFR 110.10(c)

Level of competency (S)

Cited by Andrew M Kupper, Ariel J Cutchins

11 Jul 2016
21 CFR 110.35(a)

Buildings/good repair

Cited by Andrew M Kupper, Ariel J Cutchins

11 Jul 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Andrew M Kupper, Ariel J Cutchins

11 Jul 2016
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Andrew M Kupper, Ariel J Cutchins

Inspected site

BRBB Riverboats Inc. - The LandingNewport, United States

Inspection team

AJAriel J Cutchins

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations3x
21 CFR 110.80Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)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)(3)Cited across public-safe Form 483 observations1x
21 CFR 1250.32(a)Cited across public-safe Form 483 observations1x
21 CFR 1250.82(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 18 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