Abbott 17-March-99 In vitro diagnostic products
2. Failure to document all activities required by 21 CFR 820.100(b) as they relate to corrective and preventive action. For example:
a. There is no documentation of the management review and approval of the decision not to send a customer communication to alert Axsym instrument users of a system software defect which causes incorrect test results to be reported.
b. The design verification test performed for the Abbott Commander _____ software version _____ identified unit test failures. Repeat testing did not include test failures or address failure to meet specifications. Management review of the _____ verification test indicated no problems were identified.
