Blue Ocean Medical Products, LLC - Dec. 23, 2014
Issue Date
Dec 23, 2014
Region
Northeast
Category
Device
$117.00
Contact Name
James T. Ledgerwood
Contact Title
President & CEO
Address 1
135 Calkins Rd.
Address 2
Ste. 600
City
Rochester
State
NY
Zip/Postal Code
14623
Country
United States
Inspection Range
Dec 17, 2014 - Dec 23, 2014
Pages
4
First Observation
Procedures for control and distribution of finished devices have not been adequately established.
Investigator(s): Nicholas C. Mendiola