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Fall Prevention receives warning letter

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 29, 2008

Fall Prevention Technologies failed to follow current Good Manufacturing Practices for its Balanceback iNVG devices, according to an FDA warning letter.

• Establish adequate quality system procedures for corrective and preventive action complaints, design controls, and records
• Establish and maintain procedures for implementing corrective and preventive action
• Implement procedures for receiving, reviewing, and evaluating complaints
• Ensure service reports include applicable test and/or inspection data following the completion of service
• Review associated data and documentation for all finished devices before they are released for distribution
• Establish a device master record
• Implement procedures to control the design of a device in order to ensure that specified design requirements are met
• Store records in a manner to minimize deterioration and loss

Fall Prevention issued two letters in response to the FDA investigator’s observations and said it planned to gradually implement corrective actions over the next five months. The FDA said it could not assess the adequacy of some of the corrective actions because Fall Prevention needed to update the procedures and retrain employees.

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