FDA WARNING_LETTER - Spes Medica srl - October 04, 2012

The FDA issued a Warning Letter to Spes Medica Srl following an inspection from October 1-4, 2012, in Battipaglia, Italy, which found their Electromyography Needles to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System regulation (21 CFR Part 820). The firm's November 1, 2012, response to the FDA 483 observations was largely deemed inadequate. Key violations include failures in design change procedures (21 CFR 820.30(i)), maintaining Device Master Records (21 CFR 820.181), controlling environmental conditions (21 CFR 820.70(c)), documenting Corrective and Preventive Actions (21 CFR 820.100(b)), establishing equipment maintenance schedules (21 CFR 820.70(g)(1)), maintaining Device History Records (21 CFR 820.184(e)), and conducting independent quality audits (21 CFR 820.22). The FDA noted that the firm's proposed corrective actions often lacked retrospective reviews, personnel training, or complete documentation. Spes Medica Srl must provide a written response within fifteen business days detailing specific corrective and preventive actions, including systemic changes and a timetable for completion, with English translations of all documentation. Failure to address these issues could impact federal contracts, premarket approvals, and Certificates to Foreign Governments, indicating serious systemic problems requiring thorough investigation.