FDA 483 - Natural Technology LLC - March 01, 2024

An FDA inspection of Natural Technology LLC dba NaturTech LLC in Terrell, TX, revealed numerous deficiencies in their manufacturing of drug and homeopathic products. The firm failed to perform adequate component testing, lacked proper microorganism testing for finished products, and operated an unvalidated water system. Significant issues were also noted in quality control unit responsibilities, equipment maintenance, instrument calibration, and facility upkeep, indicating a broad lack of adherence to good manufacturing practices.