Atlas

Form 483

G&T Diabetes Solutions, Corp Form 483, 2014-10-02

FDA issued a Form 483 to G&T Diabetes Solutions, Corp on 2014-10-02 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

G&T Diabetes Solutions, Corp · Guaynabo, United States · Issued October 2, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Oct 2014
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Wanda J Torres

2 Oct 2014
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Wanda J Torres

Inspected site

GDG&T Diabetes Solutions, CorpGuaynabo, United States

Inspection team

WJWanda J Torres

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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