FDA 483 - Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) - April 24, 2019

An FDA inspection of Synvisis Life Technologies, Inc. in Saint Paul, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including missing effectiveness checks and proper tracking of audit-related CAPAs. Additionally, process control procedures for products like Peri-Strip Dry Verifas Linear were found to be inadequately defined.