# FDA 483 - Curium US PET LLC - April 18, 2025

Source: https://www.keypedia.com/records/483/curium-us-pet-llc/cf532db8-b7a4-4eac-b7a1-ecf3881080d1

> FDA 483 for Curium US PET LLC on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curium US PET LLC
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Curium US LLC in Noblesville, Indiana, a drug substance and drug product manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate controls over computer systems and electronic data, insufficient investigations into out-of-specification laboratory results, and failures in aseptic processing procedures to prevent microbiological contamination of sterile drug products. These issues indicate a lack of robust quality control and data integrity practices.

## Related Officers

- [Senior Consumer Safety Officer](https://www.keypedia.com/people/carla-j-lundi/a10ed698-54fe-4635-a766-8c31f501dfb2)
- [Yiwu Li](https://www.keypedia.com/people/yiwu-li/c5fbe4f3-894d-4408-a408-56d100e118ad)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

Company: https://www.keypedia.com/companies/curium-us-pet-llc/0bdd3dc2-1a8a-46ec-819b-0a1d58ac2e15

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