The FDA has issued a warning letter to Applied Water Engineering of Salt Lake City about manufacturing its dialysis devices without conducting quality audits or performing compliant response procedures.
The FDA inspected the facility in July 2006 and found nearly a dozen violations of current good manufacturing practice requirements for the company’s PA2000 and SPD reverse osmosis water purification systems for dialysis, and the Bicarb Mixer.
Among the violations was a failure to identify, document, and get approval of design changes before their implementation as well as a failure to maintain management review procedures and personnel training documents.
If Applied Water Engineering doesn’t promptly correct these violations it may face regulatory action from the FDA, which would include seizure, injunction, and civil money penalties.
The warning letter can be viewed on the FDA’s Web site.