FDA 483 - Central Solutions Inc - November 21, 2019

An FDA inspection of Central Solutions Inc, an OTC drug, medical device, and cosmetic manufacturer in Kansas City, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to thoroughly investigate discrepancies, justify deviations from specifications, and maintain adequate written procedures for production, process controls, and stability testing. Additionally, issues were noted with equipment cleaning, raw material release, and employee training.