FDA WARNING_LETTER - H & A Mui Enterprises Inc. - August 05, 2011

On August 2-5, 2011, an FDA inspection of H & A Mui Enterprises Inc. in Mississauga, Canada, revealed that their motility catheters and pressurized manometric pumps are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), lacking design plans, inputs, outputs, reviews, verification/validation, transfer, and design history files. The firm's Quality Manual explicitly excluded Design and Development from its quality management system. 2. Failure to establish and maintain procedures for design change control (21 CFR 820.30(i)), with inadequate implementation of the "New Product/Change Control" form. 3. Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), lacking a designated unit, uniform processing, documentation of oral complaints, and MDR reportability evaluation. 4. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), with deficiencies in data analysis, nonconformity investigation