# FDA 483 - Alcami Carolinas Corporation - April 05, 2024

Source: https://www.globalkeysolutions.net/records/483/alcami-carolinas-corporation/9d9b8e36-2052-409e-8d46-494727866ac8

> FDA 483 for Alcami Carolinas Corporation on April 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2024-04-05
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Alcami Carolinas Corporation, a sterile drug manufacturer in Charleston, SC, revealed a significant issue within its laboratory control system. The firm failed to follow established specifications and test procedures, leading to analyst errors during testing runs for a Sodium Chloride Diluent batch. These errors resulted in an out-of-specification value, indicating a breakdown in adherence to training and procedural guidelines.

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## Related Officers

- [Owner/Inspector](https://www.globalkeysolutions.net/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [ CSO](https://www.globalkeysolutions.net/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [Rodney L. Tinzie](https://www.globalkeysolutions.net/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)

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

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