Form 483

HornBlower Cruises and Events LLC Form 483, 2015-11-10

FDA issued a Form 483 to HornBlower Cruises and Events LLC on 2015-11-10 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

HornBlower Cruises and Events LLC · New York, United States · Issued November 10, 2015

Overview

  • 9 public-safe observations are available for this inspection.
  • 7 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.

10 Nov 2015
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Sonia E Ortiz

10 Nov 2015
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Sonia E Ortiz

10 Nov 2015
21 CFR 110.37(e)(6)

Refuse receptacles

Cited by Sonia E Ortiz

10 Nov 2015
21 CFR 1250.33(a)

Adequate facilities for cleaning, bactericidal treatment

Cited by Sonia E Ortiz

10 Nov 2015
21 CFR 1250.33(a)

Maintained in good repair

Cited by Sonia E Ortiz

Inspected site

HCHornBlower Cruises and Events LLCNew York, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1250.33(a)Cited across public-safe Form 483 observations2x
21 CFR 1250.67Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(6)Cited across public-safe Form 483 observations1x
21 CFR 1250.33(b)Cited across public-safe Form 483 observations1x
21 CFR 1250.82(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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