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

During an inspection conducted from April 1 to April 8, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to High Technology, Inc., a manufacturer of IVD devices in North Attleboro, MA. The inspection revealed several significant compliance issues related to the company's quality management system, as mandated by FDA regulations.

Key observations included a lack of adequate validation for critical manufacturing processes such as mixing, filling/capping, and cleaning/sanitation of equipment, without proper documented rationale. The firm also demonstrated deficiencies in its Corrective and Preventive Action (CAPA) procedures, specifically failing to fully document investigations and verify the effectiveness of corrective actions for multiple issues, and not initiating CAPAs when nonconforming products were identified through customer complaints.

Further issues involved the absence of statistically valid rationales for sampling sizes used in acceptance activities (incoming, in-process, finished devices). Design validation was found inadequate, particularly regarding stability studies for reagent expiration dates, including marketing products without sufficient stability data and approving a failing stability study. High Technology, Inc. also lacked adequate procedures for evaluating and controlling suppliers, contractors, and consultants, and failed to properly investigate and document customer complaints about potential device failures.

The company's CEO, Mr. Gary Titov, was presented with these observations, and the firm reportedly promised to correct each identified deficiency. These actions are essential to ensure compliance with FDA quality system requirements and the continued safety and effectiveness of their manufactured medical devices.