FDA 483 - Tekweld Solutions Inc. - January 16, 2026

An FDA Form 483 was issued to [FIRM NAME] following an inspection conducted from January 13 to January 16, 2025. The document outlines significant observations regarding the firm's adherence to Good Manufacturing Practices (GMP) for Over-the-Counter (OTC) drug products, including SPF lip balm, hand sanitizer, and topical sunscreen. A primary concern was the deficient establishment of reliability for component supplier reports. The firm lacked a supplier verification program and failed to perform adequate testing to confirm the identity, purity, strength, and quality of bulk drug products received. This raises questions about the integrity of incoming materials. Furthermore, a critical observation was the absence of a formal quality control unit. The firm had not established written procedures for a quality unit's roles and responsibilities, nor did it possess a Change Management Program to govern modifications to equipment, facilities, or software. Employee training was also found lacking, with insufficient frequency of GMP training and an absence of documented training procedures. Lastly, the inspection identified inadequate environmental controls for drug product storage. The firm failed to implement necessary temperature and humidity monitoring in its warehouse, potentially compromising the identity, strength, quality, and purity of stored OTC drug products. These observations collectively indicate a need for comprehensive corrective actions to ensure compliance with regulatory standards and safeguard product quality.