International Immuno-Diagnostics, Inc. - January 3, 2011
Issue Date
Jan 03, 2011
Region
Pacific
Category
Device
$117.00
Address 1
1155 Chess Dr.
Address 2
Suite 121
City
Foster City
State
CA
Zip/Postal Code
94404-1115
Country
US
Inspection Range
Dec 08, 2010 - Jan 03, 2011
Pages
4
First Observation
Corrective and preventive action activities and/or results have not been documented.
Specifically, your firm initiated five corrective and preventive actions (CAPA #1, #2, #3, #4, and #5) to address the inspectional observations from the previous FDA inspection that ended on 5/18/10. Four of the five CAPAs are currently closed and verified as effective according to the CAPA files. No documentation was available or provided to show what verification activities were performed for each of the closed CAPAs.
Investigator(s): Lydia S. ChanSpecifically, your firm initiated five corrective and preventive actions (CAPA #1, #2, #3, #4, and #5) to address the inspectional observations from the previous FDA inspection that ended on 5/18/10. Four of the five CAPAs are currently closed and verified as effective according to the CAPA files. No documentation was available or provided to show what verification activities were performed for each of the closed CAPAs.