FDA WARNING_LETTER - Patient Transfer Systems, Inc - May 09, 2011

On August 4, 2011, the FDA issued a Warning Letter to Patient Transfer Systems, Inc. following an inspection from April 28 to May 9, 2011. The inspection revealed that the firm's Rapid Airway Management Positioners are adulterated under section 501(h) of the Act, as manufacturing methods, facilities, or controls do not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), lacking specific quality requirements and a design history file for the RAMP. 2. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)), including no procedure for reviewing quality data. 3. Failure to establish and maintain procedures for controlling purchased product and services (21 CFR 820.50), lacking specific quality requirements for RAMP components and its contract manufacturer. 4. Failure to maintain device master records (21 CFR 820.181) and device history records (21 CFR 820.184) for the RAMP. 5. Failure of executive management to review the suitability and effectiveness of the quality system (21 CFR 820.20(c