Day

October 10, 2002
Company:Serv-A-Pure Co.Product: Water purification systems for hemodialysis Date: 10/10/2002 Design Control and Design Inputs and Outputs. Your response to FDA-483 observation # 4 addresses the specific observation that the records were not signed and dated. We are concerned that the records referred to in this observation are maintained on a computer system, and your response...
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