FDA 483 - Cosway Company, Inc. - April 08, 2011

An FDA inspection of Cosway Company Inc., a pharmaceutical and cosmetic manufacturer, took place from March 28 to April 8, 2011. The inspection revealed critical deficiencies in the company's manufacturing processes, primarily concerning equipment cleaning and sanitization. The main violation noted was that equipment and utensils were not cleaned and sanitized at appropriate intervals to prevent product contamination, a direct non-compliance with regulatory frameworks for drug manufacturing. Specifically, the cleaning validation program for non-dedicated manufacturing equipment was found to be inadequate. There were no cleaning validations for major equipment like filling machines, transfer pumps, and hoses. Furthermore, the company's Standard Operating Procedure #17, governing cleaning, lacked specific procedures and acceptance criteria for pH testing of residual cleaning agents in rinse water. The FDA highlighted uninvestigated instances where pH values fell outside the neutral acceptance range of 5-7. To rectify these issues, Cosway Company Inc. must implement a robust cleaning validation program for all manufacturing equipment and update its Standard Operating Procedures to include comprehensive testing parameters and investigative protocols for out-of-specification results. This is essential to ensure compliance with Current Good Manufacturing Practices (cGMP) and maintain product safety and quality.