FDA 483 - High Technology, Inc. - April 08, 2019

Biol Technology, Inc., a manufacturer of IVD devices in North Attleboro, MA, received a Form FDA 483 with six observations during an inspection. The firm was cited for significant deficiencies across its quality system, including inadequate process validation, corrective and preventive action procedures, and design validation. These issues indicate a lack of robust controls over manufacturing processes, product design, and quality management.