# FDA 483 - SI Group, Inc. - January 15, 2025

Source: https://www.globalkeysolutions.net/records/483/si-group-inc/d852b16d-73ec-4972-964d-7af3362c1901

> FDA 483 for SI Group, Inc. on January 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SI Group, Inc.
- Inspection Date: 2025-01-15
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: SI Group, Inc. in Orangeburg, SC, an Active Pharmaceutical Ingredient manufacturer, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in the calibration and verification of scales used in Propofol API packaging operations, a lack of proper second verification for packaged API weight, and uncertified areas within the packaging cleanroom. These issues indicate potential concerns with quality control and environmental monitoring in their manufacturing processes.

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [investigator](https://www.globalkeysolutions.net/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)

Company: https://www.globalkeysolutions.net/companies/si-group-inc/6f15e9d4-610c-474c-907b-9d9d3b5621f3

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7