# FDA 483 - Alcami Carolinas Corporation - February 06, 2026

Source: https://www.keypedia.com/records/483/alcami-carolinas-corporation/22cedd37-381b-49fa-baf6-77e907ee825e

> FDA 483 for Alcami Carolinas Corporation on February 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Alcami Carolinas Corporation in Charleston, SC, revealed significant deficiencies in the manufacturing of sterile drug products. Observations included incomplete performance qualification studies for critical equipment, inadequate and untimely investigations into out-of-specification bioburden results, and a deficient environmental monitoring system. The findings indicate a lack of robust controls to ensure the quality and sterility of drug products.

## Related Documents

- [483 - 2017-12-15](https://www.keypedia.com/records/483/alcami-carolinas-corporation/43fdd0da-2fac-49b5-b8e7-d9ef299b6e96)
- [483 - 2021-10-29](https://www.keypedia.com/records/483/alcami-carolinas-corporation/d9e81f65-45dd-4025-a4f2-4ad66bd4da9c)
- [483 - 2024-04-05](https://www.keypedia.com/records/483/alcami-carolinas-corporation/9d9b8e36-2052-409e-8d46-494727866ac8)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/alcami-carolinas-corporation/87394b03-3fcf-4acb-836a-8c46cc6881c2

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