Abbott Laboratories Internal Complaint Handling

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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