# FDA 483 - Carolina Infusion - August 12, 2022

Source: https://www.keypedia.com/records/483/carolina-infusion/25877f6e-2c42-4659-ad82-d719e4556ff8

> FDA 483 for Carolina Infusion on August 12, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Carolina Infusion
- Inspection Date: 2022-08-12
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Carolina Infusion, a producer of sterile and non-sterile drug products in Ridgeland, SC, was cited for significant deficiencies in its manufacturing processes. Observations included inadequate endotoxin control for intrathecal products, insufficient media fill challenges, uncertified ISO-5 areas under dynamic conditions, and critical issues with facility environmental control, including pathogenic microbial contamination and the use of non-pharmaceutical grade components. These findings indicate a serious lack of assurance in the sterility and quality of drug products.

## Related Documents

- [483 - 2022-08-12](https://www.keypedia.com/records/483/carolina-infusion/933a4fc2-d73b-4892-a87f-ca8a43493467)
- [483 - 2025-01-24](https://www.keypedia.com/records/483/carolina-infusion/c3980467-1d71-4fe5-914b-059654564d63)

## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)

Company: https://www.keypedia.com/companies/carolina-infusion/a1dadac6-a332-4476-b2f1-952c2a6cc5cf

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