# FDA 483 - ISP Chemicals LLC - July 14, 2025

Source: https://www.keypedia.com/records/483/isp-chemicals-llc/55e52891-ecb6-471c-83d5-5800cc4c3208

> FDA 483 for ISP Chemicals LLC on July 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ISP Chemicals LLC
- Inspection Date: 2025-07-14
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of ISP Chemicals LLC, an API manufacturer in Calvert City, KY, identified two significant issues. The firm failed to use validated and stability-indicating test procedures, specifically lacking a degradation study and established potential degradation products for their API. Additionally, the inspection found that sampling procedures for finished API drug products were not scientifically justified, leading to non-representative samples for quality assessment.

## Related Documents

- [EIR - 2019-01-10](https://www.keypedia.com/records/eir/isp-chemicals-llc/dfb09ae5-b023-4477-83e8-d7ae2619ed5b)
- [EIR - 2019-10-02](https://www.keypedia.com/records/eir/isp-chemicals-llc/1486202c-9d69-4550-a02f-5589e778870e)
- [483 - 2025-07-17](https://www.keypedia.com/records/483/isp-chemicals-llc/3874ddd7-b169-4ba4-b802-4b2416d135f5)

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.keypedia.com/companies/isp-chemicals-llc/c03a5939-e6de-4899-8925-a5565d913c94

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22