FDA WARNING_LETTER - Meridian Medical Systems LLC - May 31, 2013

An FDA inspection of Meridian Medical Systems, LLC, conducted from May 13-31, 2013, revealed that the firm's x-ray systems are adulterated and misbranded. The devices were found adulterated under 21 U.S.C. § 351(h) due to non-conformity with the 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 21 CFR Part 803 (Medical Device Reporting). Significant QS violations include the failure to establish a design history file (21 CFR 820.30(j)), adequately establish corrective and preventive action procedures (21 CFR 820.100(a)), define and document control over suppliers (21 CFR 820.50(a)(2) and (a)(1)), establish device history record procedures (21 CFR 820.184), and establish finished device acceptance procedures (21 CFR 820.80(d)). Additionally, the firm failed to develop and implement written procedures for Medical Device Reporting (21 CFR 803.17). The firm's June 17, 2013, response to the FDA 483 was deemed inadequate. Meridian Medical Systems must take prompt action to correct all violations and provide a comprehensive written response within fifteen business days, detailing specific corrective and preventive actions, including documentation and a timetable if necessary. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on premarket approvals and Certificates to Foreign Governments.