Form 483

Circle Line Sightseeing Yachts Inc Form 483, 2011-03-22

FDA issued a Form 483 to Circle Line Sightseeing Yachts Inc on 2011-03-22 with 5 public-safe observations.

483· Form 483 issued5 observations

Circle Line Sightseeing Yachts Inc · New York, United States · Issued March 22, 2011

Overview

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

22 Mar 2011
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Sonia E Ortiz

22 Mar 2011
21 CFR 1250.32(a)

Contamination

Cited by Sonia E Ortiz

22 Mar 2011
21 CFR 1250.33(a)

Maintained in good repair

Cited by Sonia E Ortiz

22 Mar 2011
21 CFR 1250.33(c)

Storage and handling after bactericidal treatment

Cited by Sonia E Ortiz

22 Mar 2011
21 CFR 1250.34

Thermometers

Cited by Sonia E Ortiz

Inspected site

CLCircle Line Sightseeing Yachts IncNew York, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 1250.32(a)Cited across public-safe Form 483 observations1x
21 CFR 1250.33(a)Cited across public-safe Form 483 observations1x
21 CFR 1250.33(c)Cited across public-safe Form 483 observations1x
21 CFR 1250.34Cited 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