Biolase: FDA warning follows facility inspection

By Lisa Kerner

Charlotte, N.C., Sept. 11 - Biolase Technology, Inc. received a warning letter from the Food and Drug Administration following an August inspection of the company's Irvine, Calif., facility.

The FDA letter cites certain aspects of the manufacture, packing, storage or installation of the company's devices that are not in compliance with the agency's Good Manufacturing Practice requirements.

Biolase, a medical technology company, said it is working with the FDA to resolve all the cited matters and does not expect the warnings to impact its operating results.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.