# FDA 483 - Alcami Carolinas Corporation - March 28, 2017

Source: https://www.globalkeysolutions.net/records/483/alcami-carolinas-corporation/0f18c1a2-9fcd-4b5b-9008-62e67bfa66f3

> FDA 483 for Alcami Carolinas Corporation on March 28, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2017-03-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: During an inspection, Alcami Corporation, a contract testing laboratory in Affton, MO, was cited for two significant issues. Inspectors found that USP reference standards were improperly stored at room temperature instead of in a refrigerator, indicating a failure in laboratory control mechanisms. Additionally, the firm lacked appropriate controls over computer systems, as analysts could freely change time and date settings on critical laboratory equipment, raising concerns about data integrity.

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- [483 - 2024-10-04](https://www.globalkeysolutions.net/records/483/alcami-carolinas-corporation/80cd08d4-8fc8-4314-b6f6-916af55416a3)

## Related Officers

- [Tiara N Brown-Crosen](https://www.globalkeysolutions.net/people/tiara-n-brown-crosen/8255649d-25a9-49fa-a28d-0cdda922c0c3)

Company: https://www.globalkeysolutions.net/companies/alcami-carolinas-corporation/bc876747-1f37-4ea6-9e86-c152c19f219e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8