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Safer Sleep.

Publication: Warning Letter Bulletin
Publication Date: 01-JUN-08 		Format: Online
Delivery: Immediate Online Access
Full Article Title: Safer Sleep.(MEDICAL DEVICES)

Article Excerpt
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...

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