Recipient: LifeScan Inc.
Product: OneTouch Ultra and OneTouch UltraSmart Blood Glucose Readers
Date: 12/7/20055
Your October 6, 2005 response also describes the need to validate changes planned for your electronic complaint handling system. Again, a timeline for the completion of your validation study was not provided. The validation of your complaint handling system and the training of your employees are critical to prevent the recurrence of this observation. Without the review of your preventive action(s), it is difficult to gauge your compliance to the regulation. Upon the completion of your system validation and the training of your employees to the new complaint handling system, please provide the District Office with your documents.
FDA District: San Francisco District Office
