# FDA 483 - Alcami Carolinas Corporation - March 13, 2023

Source: https://www.keypedia.com/records/483/alcami-carolinas-corporation/65e0e803-2088-4ee7-92bb-6fbb49859cfd

> FDA 483 for Alcami Carolinas Corporation on March 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2023-03-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Alcami Carolinas Corporation in Durham, NC, a contract manufacturer and testing laboratory, revealed two significant observations. The firm failed to thoroughly review unexplained discrepancies in batch records, including issues with actual yield specifications and justifications for variations in sterile injectable drug product manufacturing. Additionally, drug product samples were not properly identified, and the firm's SOP for sample handling was found to be deficient.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab