FDA Cites Devicemaker Over Auditing, CAPAs, Complaint Handling

Palo Alto Health Sciences drew a Form 483 from the FDA for inadequate CAPA and complaint procedures, and for incomplete internal auditing and supplier profiles.

The agency observed in its October 2017 inspection that the facility’s complaint handling procedure required all product complaints to be assessed for adverse event reporting.

However, none of the company’s complaints from 2016 or 2017 reviewed by the FDA had been evaluated to determine whether they should be reported to the agency as adverse events.