Multiple Violations at 3 Royal Philips Facilities

FDA inspections at three Royal Philips medical device manufacturing facilities — Bothwell, WA, Reedsville, PA, and Eindhoven, Netherlands — identified Quality System Regulation and other violations in the firm’s manufacturing of several medical devices. A just-released 9/9 Warning Letter says the specific violations were:

• failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
• failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
• failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguity and errors are resolved before devices are released for distribution;
• failure to establish and maintain procedures for implementing corrective and preventive action, including analyzing processes, work operations, concessions, quality audit reports, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems;
• failure to establish and maintain procedures for implementing corrective and preventive action, including verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
• failure to establish and maintain procedures for validating the device design, including risk analysis, where appropriate;
• failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities;
• failure to submit any report required within 10 working days of initiating a correction or removal;
• failure to report required information no later than 30 days after the day that the firm received or otherwise became aware of information, from any source, reasonably suggesting that a marketed device had malfunctioned and the device or a similar one that the firm markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;

The letter says the three facilities should take prompt action to address the violations. Royal Philips was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the actions and a schedule for completing them.