FDA WARNING_LETTER - Michigan Medical Innovations - April 16, 2012

The FDA issued a Warning Letter to Michigan Medical Innovations following an April 2-16, 2012, inspection of their Ada, Michigan facility, which manufactures the DVT Care CA5 Compression Limb Sleeve. The device was deemed adulterated under section 501(h) of the Act due to non-conformity with Quality System (QS) regulation, 21 CFR Part 820. The inspection revealed 13 significant violations, including failures in establishing and maintaining procedures for design changes, corrective and preventive actions (CAPA) implementation and documentation, process validation, control of nonconforming products, incoming product acceptance, complaint handling and MDR evaluation, supplier quality requirements, personnel training, management review of the quality system, internal quality audits, and document control. Specific CFR citations include 820.30(i), 820.100, 820.75(a), 820.90, 820.80(b), 820.198(a), 198(b), 820.50, 820.25(b), 820.20(c), 820.22, and 820.40. The firm's April 27, 2012, response was inadequate as corrections were not implemented. Michigan Medical Innovations must promptly correct all violations, providing a written response within fifteen business days detailing specific corrective actions, prevention plans, documentation, and a timetable. Non-compliance could lead to regulatory actions like seizure, injunction, civil money penalties, and negatively impact federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter stresses the need to address systemic quality management issues.