FDA 483 - Kesin Pharma - January 19, 2024

Kesin Pharma, a repacker/relabeler in Oldsmar, FL, was cited for multiple significant deficiencies in its quality systems during an FDA inspection. Observations included a lack of stability testing, inadequate process and cleaning validations, deficient equipment calibration, and missing component specifications. Additionally, the firm failed to complete temperature mapping for its storage warehouses, indicating a broad failure to adhere to cGMP regulations.