FDA WARNING_LETTER - Soring Medical Technology - December 02, 2011

The FDA issued a Warning Letter to Soring Medical Technology following an inspection from November 17 to December 2, 2011, at their Doral, FL facility. As an initial distributor of Class II devices manufactured by Soring GmbH, the firm is required to comply with 21 CFR 820 Quality System Regulations. The inspection revealed devices are misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 U.S.C. § 360(i) and 21 CFR Part 803, specifically lacking adequate Medical Device Reporting (MDR) procedures (21 CFR 803.17). Furthermore, the devices were found adulterated under 21 U.S.C. § 351(h) due to non-conformity with current good manufacturing practice requirements of 21 CFR Part 820. Significant Quality System deficiencies included: failure to establish adequate procedures for corrective and preventive action (21 CFR 820.100(a)), complaint handling (21 CFR 820.198), quality system instructions (21 CFR 820.20(e)), environmental controls (21 CFR 820.70(c)), and document control (21 CFR 820.40). Additionally, personnel lacked necessary training (21 CFR 820.25(a)), and procedures for identifying training needs were absent (21 CFR 820.25(b)). The firm's responses to the FDA 483 were deemed inadequate due to insufficient documentation. Soring Medical Technology must promptly correct these violations within fifteen business days, providing detailed corrective actions and a timetable, or face potential regulatory actions including seizure, injunction, and civil money penalties.