FDA 483 - Tekweld Solutions Inc. - January 16, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Office
- New York District Office
- Person
ID · c4a85287-53e0-4e7c-a242-5b79f8d2527e