# FDA 483 - REGI US INC - January 22, 2025

Source: https://www.globalkeysolutions.net/records/483/regi-us-inc/901ea55e-191b-45b9-9fe6-aee542eb6d79

> FDA 483 for REGI US INC on January 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: REGI US INC
- Inspection Date: 2025-01-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: REGI US INC in West Caldwell, NJ, a drug manufacturer, received a Form FDA 483 with four observations during an inspection from January 14-22, 2025. The inspection revealed significant deficiencies in production and process controls, quality unit responsibilities, supplier qualification, and record keeping, particularly concerning sunscreen drug products. These issues indicate a lack of adherence to good manufacturing practices and proper quality oversight.

## Related Officers

- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)
- [Jenny Sung](https://www.globalkeysolutions.net/people/jenny-sung/f0bfe57e-92b9-4879-9ac3-1e3483b6486a)

Company: https://www.globalkeysolutions.net/companies/regi-us-inc/0596d9b3-58c6-48ab-89fb-096ab585b2dd

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248