FDA 483 - Techlem Medical Corporation - June 22, 2023

Techlem Medical Corporation received an FDA Form 483 following an inspection conducted from June 19 to June 22, 2023. The inspection identified eight significant observations indicating systemic deficiencies in the company's quality management system for medical device manufacturing. Key issues included a fundamental lack of adequately established procedures across several critical areas, such as corrective and preventive actions (CAPA), internal quality audits, and maintaining a complete design history file for its devices. Furthermore, documentation practices were found lacking, with acceptance activities not adequately recorded and device history record procedures undefined. The firm also failed to upload required medical device information to the Global Unique Device Identification Database (GUDID).

Additional observations highlighted inadequate procedures for ensuring that purchased products and services conform to specifications, particularly concerning vendor approval processes. Comprehensive document control procedures, essential for managing electronic records, work instructions, and quality records, were also not adequately established or maintained. These observations indicate a need for Techlem Medical Corporation to enhance its adherence to regulatory quality system requirements. The company's President/CEO, Dr. Anurag Sinha, committed to correcting all identified issues.