Company: Fresenius Medical CareDate: 7/25/02 Product: Naturalyte Acid Concentrate Your firm failed to validate the new salt delivery system for process deviation 2002-005 dated February 1, 2002 for Naturalyte Acid Concentrate lot 2B0017 as required by 21 CFR 820.75. Furthermore, the new computer software included with the new salt delivery system is not validated for...Read More
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