Devicemaker Hit for Auditing, CAPAs, Complaint Handling Issues

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 inspection that the facility’s complaint handling procedure required all product complaints to be assessed for medical device reporting. However, none of the company’s complaints reviewed from 2016 or 2017 were evaluated to ensure they met MDR requirements.

Corrective and preventative actions were not properly documented, the agency found. The firm opened a CAPA to address a Freespira breathing session’s failure to upload, applying a software update to fix the issue. However, evidence of the update’s effectiveness was not documented in the CAPA.

The company also retained a supplier that did not have a supplier company profile on file, a requirement of the firm’s supplier evaluation procedure. The supplier also neglected to provide the firm a copy of its accreditation — required for suppliers approved based on accreditation. In addition, the firm’s internal audit procedure did not commit to formal internal audits of key quality system areas as required.