Genicon, Inc. - Jan. 17, 2020
Issue Date
Jan 17, 2020
Region
Southeast
Category
Device
$117.00
Contact Name
Gary W. Haberland
Contact Title
President
Address 1
6869 Stapoint Ct.
Address 2
Ste. 112 & 114
City
Winter Park
State
FL
Zip/Postal Code
32792-6603
Country
United States
Inspection Range
Jan 08, 2020 - Jan 17, 2020
Pages
12
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
Investigator(s): Richard K. Vogel