August 5, 2014
Detroit may be struggling with bankruptcy. However, in a flurry of activity that would make industrialist Henry Ford proud, the local FDA office has been active in our latest warning letter round-up.
FDA Warning Letter to Med-Mizer (Indiana Hospital Bed Manufacturer)
Indiana-based Med-Mizer, manufacturer of AC-powered, adjustable, and bariatric hospital beds, was hit by the FDA’s Detroit office with a 12-point letter dated July 21.
Among FDA’s accusations, Med-Miser failed to:
- Establish procedures for reviewing and evaluating incoming complaints
- Develop, conduct and control, and monitor its production process
- Establish and maintain design controls
- Validate a manufacturing process
- Ensure its products meet acceptance criteria
Ventilab LLC Cited for CAPA and Risk Management Failures
Ventilab LLC, a manufacturer of manual resuscitation bags based in Grand Rapids, was also dinged by the Detroit office for CAPA shortcomings. The company faced issues with inadequate complaint management. Furthermore, they failed to establish an acceptable risk management plan.
Philadelphia FDA Office Targets Sleep Apnea Monitor Manufacturer
Moving east to the City of Brotherly Love, FDA’s Philadelphia District office sent a warning letter to the maker of a sleep apnea monitor. They cited it for failure to ensure its device conformed to specifications and requirements. The June 30 letter was the result of a series of April 2014 inspections.
Zynex Medical Faces CAPA and Design Control Issues
A June 27 letter called out Zynex Medical. The manufacturer of the NexWave and IF8000 electrical stimulators had perceived CAPA and design control and verification shortcomings. Zynex, based in Lone Tree, Colorado, was also hit for failure to have adequate device master records. In addition, they faced issues with internal audit procedures.
Dexta Corporation Warned Over Training and Process Failures
Out in Napa, California, where the weather is lovely and the wine flows, June 25 was probably not a day to celebrate for Dexta Corporation, manufacturer of medical chairs used for Lasik surgery and other procedures. The FDA cited them for, among other things, failure to adequately train personnel, inability to verify test results, CAPA issues, and process control problems.
Closing Thoughts: FDA’s Recent Surge in Enforcement
Henry Ford, a man who tried to build his own utopian city in the jungles of the Amazon and modestly named it Fordlandia, would be proud of the FDA’s devotion to hard work these past few months. Perhaps there is an FDAlandia on some city planner’s drawing board just waiting for the green light. You never know.
