FDA 483 - Tekweld Solutions Inc. - January 16, 2025

Tekweld Solutions Inc. in Hauppauge, NY, a drug relabeler, received a Form 483 with three observations during an FDA inspection. The firm demonstrated significant deficiencies in establishing a supplier verification program for bulk drug products and performing adequate testing. Furthermore, the company lacked a formal quality control unit, a change management program, and sufficient GMP training, alongside failing to implement necessary temperature and humidity controls for drug product storage.