FDA 483 - Tishcon Corp - November 20, 2017

An FDA inspection of Cathoon Corp, a dietary supplement manufacturer in Westbury, NY, revealed significant deficiencies in quality control and product specification verification. The firm failed to adequately test finished dietary supplements, properly manage out-of-specification raw materials, and provide sufficient documentation for in-process and component specifications. These observations indicate a lack of robust quality assurance practices for their products.