FDA WARNING_LETTER - International Medical Development Corporation - March 19, 2015

On March 16-19, 2015, an FDA inspection of International Medical Development Corp. in Huntsville, Utah, found that their Gertie Marx Needles were adulterated and misbranded. The needles, cleared for regional anesthesia in adults, were promoted for unapproved uses including lumbar puncture, myelogram, and pediatric use, constituting major changes without new premarket notification (510(k)) or premarket approval (PMA). This violates sections 501(f)(1)(B) and 502(o) of the Federal Food, Drug, and Cosmetic Act.

Additionally, the firm's quality system had significant deficiencies under 21 CFR Part 820. Violations included failure to control nonconforming products (820.90(a)), maintain records of acceptable suppliers (820.50(a)(3)), establish and document acceptance activities (820.80(a), 820.80(e)), and maintain adequate device history records (820.184) and device master records (820.181). Previous responses from the firm were deemed inadequate, lacking sufficient detail, revised documentation, or implementation plans.

International Medical Development Corp. must immediately cease activities causing misbranding/adulteration and provide a written response within fifteen business days detailing corrective actions, including systemic changes, and a timetable for completion.