Form 483

Calling All Ships, LLC Form 483, 2014-09-02

FDA issued a Form 483 to Calling All Ships, LLC on 2014-09-02 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Calling All Ships, LLC · Miami, United States · Issued September 2, 2014

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.

2 Sep 2014
21 CFR 110.20(b)(1)

Sufficient space

Cited by Michael C Lombardi

2 Sep 2014
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Michael C Lombardi

2 Sep 2014
21 CFR 110.20(b)(7)

Screening

Cited by Michael C Lombardi

2 Sep 2014
21 CFR 110.37(b)(5)

Backflow prevention

Cited by Michael C Lombardi

2 Sep 2014
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Michael C Lombardi

Inspected site

CACalling All Ships, LLCMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)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)Cited 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