International Immuno-Diagnostics, Inc.
Product DetailsCorrective 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.