Apnea Sciences Corporation - Sept. 18, 2015
Issue Date
Sep 18, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
James C. Fallon
Contact Title
President/CEO
Address 1
27121 Aliso Creek Rd.
Address 2
#140
City
Aliso Vieja
State
CA
Zip/Postal Code
92656
Country
United States
Inspection Range
Sep 08, 2015 - Sep 18, 2015
Pages
5
First Observation
The design history file does not demonstrate that the design was developed following the approved design plan and design control requirements of 21 CFR 820.
Investigator(s): Charles L. Larson