Registration Lapse, GMP Violations Lead to FDA Warning Letter

Crystal Care International has been cited for manufacturing hearing aids in an unregistered facility, according to an FDA warning letter. An inspection of the company’s Lutz, Fla., facility last December revealed that the company did not have a device listing for its products and that the registration for the plant was not current, the FDA says. Crystal Care also did not have procedures for implementing corrective and preventive actions (CAPA) or for documenting CAPA activities, according to the May 22 letter, which was posted recently to the FDA website.
The GMP Letter