CT Health Solutions, LLC – FDA EIR, Jan 30, 2018

An FDA inspection of CT Health Solutions, a dietary supplement manufacturer based in Homosassa, FL, was conducted from January 19-30, 2018. This comprehensive inspection, initiated as a complaint follow-up, revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, primarily governed by 21 CFR Part 111. The inspection culminated in an 8-item FDA-483, detailing several critical observations. Major violations included the absence of established product and component specifications for identity, purity, strength, and composition for all dietary supplements. The firm also failed to implement adequate quality control operations, such as testing raw ingredients or finished products. Other issues noted were the lack of effective measures to prevent foreign material inclusion (e.g., metal detection), insufficient precautions to prevent contamination during manufacturing (including allergen management and storage practices), and a lack of specifications for packaging and labeling. Additionally, hand-washing facilities were found to be inconvenient for the manufacturing areas. One observation concerning the collection of representative samples was rectified during the inspection. Management committed to correcting the remaining issues within specified timeframes, ranging from two weeks to one year. The company was required to submit a formal response to the FDA-483 within 15 working days, detailing its proposed corrective actions.