Horiba Instruments, Inc. - 3/1/2012
Issue Date
Mar 01, 2012
Region
Pacific
Category
Device
$117.00
Address 1
34 Bunsen Dr.
City
Irvine
State
CA
Zip/Postal Code
92618
Country
United States
Inspection Range
Feb 15, 2012 - Mar 01, 2012
Pages
5
First Observation
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups and reviews by a designated person was not included in the record.
Investigator(s): Vickie L. Anderson and Angela Shepas