FDA 483 - Kesin Pharma - January 19, 2024

Kesin Pharma, an Oldsmar, FL-based repacker/relabeler, underwent an FDA inspection from January 17-19, 2024. The inspection revealed six significant observations documented on a Form FDA 483, indicating deficiencies in compliance with manufacturing regulations. Key issues included the absence of a written stability testing program and corresponding data for several drug products, such as Dextromethorphan HBr and Guaifenesin Oral Solution, and Mupirocin 2% ointment.

The firm also failed to establish comprehensive written procedures for production and process controls, with only a minimal number of products having completed Process Performance Qualification since operations began in May 2022. Cleaning and maintenance procedures for equipment were found inadequate, with cleaning validation performed for only one product despite processing multiple others. Additionally, routine calibration of automatic and mechanical equipment, including scales, was not consistently performed, and standard weights lacked proper calibration.

Deficiencies in component testing were noted, specifically the lack of written specifications for incoming materials used in unit dose cups for various drug products. Lastly, the warehouses used for storing drug products lacked complete temperature mapping, raising concerns about environmental control. Kesin Pharma is required to address these observations to ensure their manufacturing, processing, packing, and holding of drug products comply with established quality and safety standards.