# FDA 483 - Alcami Carolinas Corporation - January 31, 2025

Source: https://www.keypedia.com/records/483/alcami-carolinas-corporation/e683890b-16bd-4ca3-a3b4-d412f96052a2

> FDA 483 for Alcami Carolinas Corporation on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Alcami Carolinas Corporation, a contract testing laboratory in Wilmington, NC, identified a significant deficiency related to their written calibration procedures. The procedures for instruments, apparatus, gauges, and recording devices were found to lack specific schedules, limits for accuracy and precision, and provisions for remedial action when limits are not met. This indicates a potential issue with the reliability and control of laboratory equipment.

## Related Documents

- [483 - 2025-09-26](https://www.keypedia.com/records/483/alcami-carolinas-corporation/af8f8c69-e5c1-487b-8db4-c133d8a121ab)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)

Company: https://www.keypedia.com/companies/alcami-carolinas-corporation/c58574ae-b205-4ac2-ae4c-ef29281b0110

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