FDA 483 - Prism Pacific Industries, LLC - January 16, 2025

An FDA inspection conducted at Prism Pacific Industries, LLC, a single-use medical device reprocessor, from January 13-16, 2025, revealed significant deficiencies in the company's quality management system. The inspection, documented in an FDA Form 483, highlighted four main observations related to adherence to medical device quality regulations.

Firstly, the company's procedures for corrective and preventive actions (CAPA) were found inadequate. They lacked clear definitions for investigations, verification of action effectiveness, and proper dissemination of quality issue information. Furthermore, existing CAPA records did not sufficiently detail investigations or verification activities.

Secondly, equipment calibration and maintenance procedures were deficient. Records for critical equipment, like a temperature monitor, lacked essential traceability information and next calibration dates. Maintenance documentation failed to provide sufficient detail on activities performed, and procedures did not outline how to address products potentially affected by out-of-tolerance equipment.

Thirdly, purchasing controls were not adequately established, with no defined quality metrics for suppliers, servicers, and contractors. Several active suppliers, including external auditors and calibration services, were absent from the Approved Vendor List.

Finally, the company lacked comprehensive written procedures for Medical Device Reporting (MDR). Key elements such as definitions of adverse events, employee responsibilities, event evaluation processes, submission timelines, and recordkeeping requirements were missing from their documentation. Although no adverse events were reported, the procedural gaps are critical.

Prism Pacific Industries, LLC is required to address these observations by implementing robust corrective actions to ensure full compliance with the Quality System Regulation for medical device manufacturers. The firm must establish, document, and execute procedures that rectify these systemic issues.