# FDA 483 - ISP Chemicals LLC - December 02, 2021

Source: https://www.globalkeysolutions.net/records/483/isp-chemicals-llc/4e30fe10-5c27-46b4-b40c-ccec8bb5dac1

> FDA 483 for ISP Chemicals LLC on December 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ISP Chemicals LLC
- Inspection Date: 2021-12-02
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: ISP Chemicals LLC in Columbus, Ohio, a non-sterile API manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in laboratory controls, including unestablished test method accuracy and inadequate stability testing for Flunixin Meglumine API. Additionally, the Quality Control unit lacked proper authority to review records and failed to qualify suppliers for critical components.

## Related Documents

- [483 - 2024-01-29](https://www.globalkeysolutions.net/records/483/isp-chemicals-llc/561c0509-a961-4100-a68a-e6e81e53dff0)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/isp-chemicals-llc/8523c955-e979-40c7-afae-92f881ffe0d0

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