FDA WARNING_LETTER - AliMed Corporation - February 06, 2008

On August 19, 2008, the FDA issued a Warning Letter to AliMed Corporation following an inspection from January 17 to February 6, 2008. The inspection revealed that AliMed's TR2 Tamper Resistant Alarms, Early Warning E-Z Release Seatbelts, Bed Sensor Pad Systems, Sit-Straight Basic Cushions, Passive Infrared Alarms, Magnetic Pull-Cord Alarms, and Basic Alarms are adulterated and misbranded.

The devices are adulterated under 21 U.S.C. 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). Violations include: 1. Failure to establish and maintain corrective and preventative action procedures (21 CFR 820.100(a)), and not analyzing quality data. 2. Failure to review, evaluate, and investigate complaints involving possible device failure (21 CFR 820.198(b)), with justifications like "not of interest." 3. Failure of complaint handling procedures to evaluate complaints for Medical Device Reporting (MDR) requirements (21 CFR 820.198(a)(3)). 4. Failure to establish a quality policy, conduct management reviews, and have a quality plan (21 CFR 82