Company: Fresenius Medical Care
Date: 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 its intended use as required by 21 CFR 820.70(i). The validation of computers or automated data processing systems that are part of production or the quality system must be validated to the extent possible to adequately assure performance. In addition, your Quality System Policy Manual under section 7.3 states that “all operations including process, equipment, tests, designs, or software which can affect product quality require the need for appropriate validations activities.”
FDA District: New Jersey District
