FDA 483 - Tekweld Solutions Inc. - January 17, 2020

Tekweld Solutions Inc., a drug relabeler in Hauppauge, NY, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacks a formal quality unit, written procedures for critical operations like labeling and training, and proper documentation for inspections and label reconciliation. These issues indicate a fundamental lack of control over its OTC drug relabeling processes.