CAI Management System, with Regard to FDA 21 CFR Part 820 (cGMP), is Certified by UL
SAN DIEGO, July 17, 2015 -- UL Registrar LLC (Stroudsburg, Pennsylvania) has issued certificate of conformance # 15-172954-1 to Cell Applications, Inc., indicating CAI’s management system is certified by UL with regard to FDA 21 CFR Part 820, Current Good Manufacturing Practice for Medical Devices. The certification pertains to the manufacturing and packaging of human and animal cell culture media. Bryce E. Carson, Senior General Manager, authorized the certificate on behalf of Underwriters Laboratories, a leading voice for global safety with nearly 9,000 employees operating more than 200 laboratories and inspection centers.
At the request of Cell Applications, UL conducted the independent third party audit to assess CAI’s conformance to numerous standards, including records, statistical techniques, and controls for process, design, production, labeling, packaging, documentation and purchasing. UL also reported on the company’s activities for product identification, traceability, acceptance, handling, storage, and distribution. Corrective and preventive actions for nonconforming products were also examined. The certification furthers CAI’s commitment to product quality and customer requirements, with increased emphasis in supporting R&D programs in pharmaceutical, biotechnology and consumer product companies.