Form 483

BB Riverboats Inc. - The Landing Form 483, 2015-05-15

FDA issued a Form 483 to BB Riverboats Inc. - The Landing on 2015-05-15 with 38 public-safe observations.

483· Form 483 issuedFoods & Cosmetics38 observations

BB Riverboats Inc. - The Landing · Newport, United States · Issued May 15, 2015

Overview

  • 38 public-safe observations are available for this inspection.
  • 33 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.

15 May 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Andrew M Kupper, Shannon A Gregory, Christian L Witkovskie

15 May 2015
21 CFR 110.10(b)(4)

Hand jewelry - remove/cover

Cited by Andrew M Kupper, Shannon A Gregory, Christian L Witkovskie

15 May 2015
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Andrew M Kupper, Shannon A Gregory, Christian L Witkovskie

15 May 2015
21 CFR 110.10(b)(5)

Glove condition

Cited by Andrew M Kupper, Shannon A Gregory, Christian L Witkovskie

15 May 2015
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Andrew M Kupper, Shannon A Gregory, Christian L Witkovskie

Inspected site

BRBB Riverboats Inc. - The LandingNewport, 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 observations2x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.40(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
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(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)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)(1)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)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(f)Cited across public-safe Form 483 observations1x
21 CFR 110.40(e)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x
21 CFR 1250.30(d)Cited across public-safe Form 483 observations1x
21 CFR 1250.38(b)Cited across public-safe Form 483 observations1x
21 CFR 1250.82(d)Cited across public-safe Form 483 observations1x
21 CFR 1250.82(e)Cited across public-safe Form 483 observations1x
21 CFR 1250.82(f)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 38 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