Promedtek, Inc. - April 6, 2017
Issue Date
Apr 06, 2017
Region
Pacific
Category
Device
$117.00
Contact Name
Daniel R. Puchek
Contact Title
President & CEO
Address 1
4110 N. Scottsdale Rd.
Address 2
Ste. 270
City
Scottsdale
State
AZ
Zip/Postal Code
85251
Country
United States
Inspection Range
Apr 04, 2017 - Apr 06, 2017
Pages
2
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Kelvin Cheung