Vitalgo, Inc. - May 28, 2015
Issue Date
May 28, 2015
Region
Southeast
Category
Device
$117.00
Contact Name
Offer Parezky
Contact Title
COO
Address 1
3520 N.W. 56th St.
Address 2
Ste. 303
City
Fort Lauderdale
State
FL
Zip/Postal Code
33309-2229
Country
United States
Inspection Range
May 11, 2015 - May 28, 2015
Pages
4
First Observation
The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
Investigator(s): Paul Licata and Karen M. Rodriguez