FDA WARNING_LETTER - EPflex Feinwerktechnik GmbH - June 13, 2013

An FDA inspection of Epflex Feinwerktechnik GmbH in Dettingen An Der Erms, Germany, from June 10-13, 2013, found that the firm's guidewire devices are adulterated under 21 U.S.C. § 351(h) due to non-compliance with the Quality System regulation (21 CFR Part 820). Key violations include the failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)), adequately control environmental conditions (21 CFR 820.70(c)), validate processes (21 CFR 820.75(a)), and control nonconforming product (21 CFR 820.90(a)). Further deficiencies involved acceptance procedures for in-process product (21 CFR 820.80(c)), defining responsibility for nonconforming product disposition (21 CFR 820.90(b)(1)), investigating complaints (21 CFR 820.198(c)), maintaining device history records (21 CFR 820.184), and establishing design history files (21 CFR 820.30(j)). Additionally, the firm failed to fulfill annual registration and device listing requirements for fiscal year 2013, rendering its devices misbranded under 21 U.S.C. § 352(o). While the firm provided a response with ongoing corrective actions and some target completion dates (e.g., DHF by Dec 31, 2013), their adequacy is pending further documentation and verification of effectiveness. The FDA warned that premarket approvals and Certificates to Foreign Governments could be withheld, and federal agencies might be advised regarding contracts until all violations are corrected.