Form 483

Circle Line Sightseeing Yachts Inc Form 483, 2012-10-01

FDA issued a Form 483 to Circle Line Sightseeing Yachts Inc on 2012-10-01 with 10 public-safe observations.

483· Form 483 issued10 observations

Circle Line Sightseeing Yachts Inc · New York, United States · Issued October 1, 2012

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

1 Oct 2012
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Sonia E Ortiz

1 Oct 2012
21 CFR 110.40(e)

Lack of thermometer

Cited by Sonia E Ortiz

1 Oct 2012
21 CFR 110.80

Reasonable precautions

Cited by Sonia E Ortiz

1 Oct 2012
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Sonia E Ortiz

1 Oct 2012
21 CFR 1250.28

Handling to avoid contamination

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 110.40(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 1250.28Cited across public-safe Form 483 observations1x
21 CFR 1250.30(d)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 1250.38(b)Cited across public-safe Form 483 observations1x
21 CFR 1250.67Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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