# FDA 483 - Alcami Carolinas Corporation - March 28, 2025

Source: https://www.keypedia.com/records/483/alcami-carolinas-corporation/73f43ecd-92e3-495c-924f-dc36791e75d3

> FDA 483 for Alcami Carolinas Corporation on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Alcami Carolinas Corporation in Morrisville, NC, resulted in a Form 483 with four observations. The firm was cited for significant deficiencies in its quality control unit procedures, inadequate written procedures for equipment cleaning and maintenance, and a lack of a written program for drug product stability testing. Additionally, the company failed to establish appropriate time limits for various production phases to ensure drug product quality.

## Related Documents

- [483 - 2023-03-13](https://www.keypedia.com/records/483/alcami-carolinas-corporation/65e0e803-2088-4ee7-92bb-6fbb49859cfd)
- [EIR - 2024-12-06](https://www.keypedia.com/records/eir/alcami-carolinas-corporation/af61d93e-fa1d-41d2-ba36-761238a16ebf)

## Related Officers

- [Karthik M. Krishnan](https://www.keypedia.com/people/karthik-m-krishnan/5ded6b7c-ef26-4a5f-b823-4eb017617d7c)
- [Ju Du](https://www.keypedia.com/people/ju-du/7937a4f4-7e9c-4de9-aabb-c7b1fac307ea)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/alcami-carolinas-corporation/b3301d1d-4fec-4888-82e6-d950811aab7c

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