Fibralign Co. - Nov. 8, 2018
Issue Date
Nov 28, 2018
Region
Pacific
Category
Device
$117.00
Contact Name
Gregory D. King
Contact Title
Chief Executive Officer/President
Address 1
32930 Alvarado-Niles Rd.
Address 2
Ste. 50
City
Union City
State
CA
Zip/Postal Code
94587-8109
Country
United States
Inspection Range
Nov 01, 2018 - Nov 08, 2018
Pages
3
First Observation
The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
Investigator(s): Quynh H. Strandberg