Abbott Laboratories 1/31/97 Internal Complaint Handling System

During the inspection, our investigator identified a serious limitation inherent in your firm’s complaint database software system. Your current database software system does not provide for the recording of multiple complaint codes for a single complaint. Consequently, some computer generated reports for management review of complaint trends may contain incomplete and/or inaccurate data, or in the case where these reports are supposed to be generated automatically, they may be either be delayed or not generated at all. We understand that your firm is aware of the system’s limitations, however, we are concerned that these limitations may have accounted, in part, for the unreasonable delay in your firm’s reaction to the matters discussed in this letter. Implementation of an improved complaint handling system as mentioned in xxx letter should be given a high priority status.