FDA WARNING_LETTER - magnificent medical equipment, inc. ( - April 04, 2008

An FDA inspection of Magnificent Medical Equipment, Inc. dba Tony Riso Company, conducted from April 2-4, 2008, revealed significant violations concerning the manufacture of their [redacted] 25/30 Ultrasonic Scaler. The devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), and misbranded under section 502(t)(2) for failing to provide required information under 21 CFR Part 803 (Medical Device Reporting).

Key deficiencies included failures to maintain device history records, adequately control production processes, ensure Device Master Records contain necessary specifications, control environmental conditions, calibrate test equipment, validate processes, establish Corrective and Preventative Action (CAPA) procedures, conduct quality audits, implement design controls, and establish complaint handling procedures. Additionally, the firm lacked written Medical Device Reporting (MDR) procedures. The FDA requires prompt corrective action, with a written response due within 15 working days detailing specific steps, prevention plans, and timelines. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts. The letter emphasizes the firm's responsibility to ensure overall compliance and address underlying systemic issues.