FDA WARNING_LETTER - Vygon GmbH & Co. KG - March 20, 2014

An FDA inspection of Vygon GmbH & Co. KG in Aachen, Germany, from March 17-20, 2014, revealed that their intravascular catheters are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Significant QS violations included failures in maintaining complaint files and procedures (820.198(a)), establishing corrective and preventive action (CAPA) procedures (820.100(a)), verifying device design (820.30(f)), defining nonconforming product disposition (820.90(b)(1)), controlling suppliers (820.50(a)(2)), and conducting quality audits (820.22).

MDR violations encompassed failures to develop written MDR procedures (803.17), submit timely reports for deaths/serious injuries (803.50(a)(1)) and malfunctions (803.50(a)(2)), maintain MDR event files (803.18(b)(ii)), and submit supplemental reports (803.56).

The firm's April 9, 2014, response was deemed inadequate, lacking evidence of completed corrective actions or implemented procedures. The FDA requires a written response within fifteen business days detailing specific, systemic corrective actions, preventative measures, and a timeline for completion. Failure to comply could impact federal contracts and Class III device premarket approvals.