IVD Research, Inc. - Sept. 18, 2015
Issue Date
Sep 18, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Kathy B. Hildebrand
Contact Title
Chief Operations Officer
Address 1
5909 Sea Lion Pl.
Address 2
Ste. D
City
Carlsbad
State
CA
Zip/Postal Code
92010
Country
United States
Inspection Range
Sep 16, 2015 - Sep 18, 2015
Pages
4
First Observation
Procedures for design change have not been adequately established.
Investigator(s): Scott K. Zika