Mar Cor Purification – FDA Warning Letter, Feb 18, 2014

On January 29-February 18, 2014, an FDA inspection of Mar Cor Purification in Plymouth, Minnesota, revealed violations of the Quality System regulation (21 CFR Part 820) for their water purification systems, classified as devices. The devices were deemed adulterated under section 501(h) of the Act.

Key violations included: 1. **Failure to establish adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: The firm did not document corrective actions for issues like CWP pump head assembly redesigns due to smoke/fire complaints and multiple design changes for CWP chemical pump intake problems in CAPAs. 2. **Failure to establish adequate complaint handling procedures (21 CFR 820.198(a))**: Complaints were not uniformly and timely processed, with several instances of delayed entry into the system. The procedure also failed to ensure adequate evaluation for Medical Device Reporting (MDR) requirements, leading to delayed MDR submissions for an electric shock and a pump burning up. 3. **Failure to investigate complaints (21 CFR 820.198(c))**: Several complaints, including a defective heating element, a sparking drive motor, a burned 24-volt plug, and a leaking flow meter, lacked proper investigations to determine root causes. 4. **Failure to