Illumina, Inc. (Carroll Park facility) - Nov. 10, 2016
Issue Date
Nov 10, 2016
Region
Pacific
Category
Device
$117.00
Contact Name
Mya B. Thomae
Contact Title
Vice President of Regulatory & Clinical Affairs
Address 1
9440 Carroll Park Dr.
City
San Diego
State
CA
Zip/Postal Code
92121
Country
United States
Inspection Range
Nov 01, 2016 - Nov 10, 2016
Pages
2
First Observation
Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
Investigator(s): Kelvin Cheung