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Safer Sleep.(MEDICAL DEVICES)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Nashville, TN, May 27 (New Orleans District)
FDA cited Safer Sleep for GMP violations resulting in the adulteration of the device, following an inspection Nov. 13, 16 and 20.
The company failed to establish and maintain procedures for validating the device design, including software validation, according to the letter. For example, the firm provided no documentation of validation of the embedded software in the SAFERsleep device.
Safer Sleep also failed to establish and maintain procedures for implementing corrective and preventive action, as well as procedures for receiving, reviewing and evaluating complaints. Although complaints were tracked through a support ...