Form 483

Pure Caribbean Distributors LLC Form 483, 2017-08-31

FDA issued a Form 483 to Pure Caribbean Distributors LLC on 2017-08-31 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Pure Caribbean Distributors LLC · Miami, United States · Issued August 31, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 Aug 2017
21 CFR 1.502(a)

Develop FSVP

Cited by Zuleika A Pineiro Vargas

Inspected site

PCPure Caribbean Distributors LLCMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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