Tekweld Solutions Inc. – FDA 483, Jan 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.
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ID · c4a85287-53e0-4e7c-a242-5b79f8d2527e
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