Form 483

Caribbean Dental Products Corp. Form 483, 2018-08-22

FDA issued a Form 483 to Caribbean Dental Products Corp. on 2018-08-22 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Caribbean Dental Products Corp. · Bayamon, United States · Issued August 22, 2018

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.

22 Aug 2018
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Annette Melendez

Inspected site

CDCaribbean Dental Products Corp.Bayamon, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.180(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