Oceanic Medical Products, Inc. - June 18, 2014
Issue Date
Jun 18, 2014
Region
Southwest
Category
Device
$117.00
Contact Name
John R. Peake
Contact Title
Manager/Chief Operating Officer
Address 1
8005 Shannon Industrial Park Ln.
City
Atchison
State
KS
Zip/Postal Code
66002
Country
United States
Inspection Range
Jun 16, 2014 - Jun 18, 2014
Pages
4
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
Investigator(s): Janete A. Eaker