# FDA 483 - JICE Pharmaceuticals Company - May 23, 2025

Source: https://www.keypedia.com/records/483/jice-pharmaceuticals-company/e6761f34-52be-4a5b-91be-9cd151cb2ee5

> FDA 483 for JICE Pharmaceuticals Company on May 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JICE Pharmaceuticals Company
- Inspection Date: 2025-05-23
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: JICE Pharmaceuticals Company in Belding, MI, received a Form FDA 483 with four repeat observations during an inspection from May 21-23, 2025. The inspection revealed significant deficiencies in drug product testing, batch record management, component supplier qualification, and the stability program. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting drug product quality.

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)

Company: https://www.keypedia.com/companies/jice-pharmaceuticals-company/bc66698e-3017-4c81-bbbb-b7cfdf16b6d3

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03