# FDA 483 - Kesin Pharma - January 19, 2024

Source: https://www.keypedia.com/records/483/kesin-pharma/bea369bc-43ed-4d98-ad5d-e504afb813c3

> FDA 483 for Kesin Pharma on January 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kesin Pharma
- Inspection Date: 2024-01-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/kesin-pharma/60b8eb12-1b78-43de-89bb-437b1fbe2c3b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6