FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Integra LifeSciences Cited for Inadequate Complaint Handling

Nov. 26, 2018
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The FDA called out Integra LifeSciences’ Cincinatti, Ohio facility for not having its complaint handling procedures up to par, hitting the devicemaker with a Form 483.

The agency noted that the firm’s procedures for receiving complaints from service requests were not adequate, as it didn’t accurately forward all service records to its corporate location for complaint processing.

Out of 31 service records reviewed by the agency, five were not properly forwarded by the firm to be investigated as complaints.

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