FDA WARNING_LETTER - Med-Mizer, Inc. - March 07, 2014

The FDA issued a Warning Letter to Med-Mizer, Inc. following a February-March 2014 inspection of their Batesville, Indiana facility, which manufactures AC powered, adjustable, and bariatric hospital beds. The inspection revealed the firm's devices are adulterated under 21 U.S.C. § 351(h) due to widespread non-conformity with the Quality System regulation (21 CFR Part 820).

Significant Quality System violations include failures in establishing and maintaining procedures for corrective and preventive actions, complaint handling, production process control, and comprehensive design control (inputs, outputs, reviews, verification, validation, and change control). Deficiencies also covered process validation, finished device acceptance, nonconforming product control, rework, purchasing controls, incoming product acceptance, Device History Records, and employee training.

The firm's Model SS Hospital Beds were misbranded for failing to report a field correction/removal (21 CFR Part 806.10), though a voluntary recall and report were later initiated. Misbranding also stemmed from lacking Medical Device Reporting (MDR) procedures (21 CFR 803.17) and failing to submit an MDR for a patient death within 30 days (21 CFR 803.50(a)(1)).

Med-Mizer's initial response was largely inadequate. The FDA requires prompt, systemic corrective actions, with a detailed written response within 15 business days, including documentation and a realistic timetable. Non-compliance may lead to severe regulatory actions, including seizure, injunction, civil money penalties, and adverse impacts on federal contracts and device approvals.