Kesin PharmaJanuary 19, 2024

FDA 483 - Kesin Pharma - January 19, 2024

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Record Details

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.

Company: Kesin Pharma
Inspection Date: January 19, 2024
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
People: Dorothy P. Kramer
Nicole E. Knowlton (Investigator )

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ID · bea369bc-43ed-4d98-ad5d-e504afb813c3