# FDA 483 - Alcami Carolinas Corporation - October 29, 2021

Source: https://www.keypedia.com/records/483/alcami-carolinas-corporation/d9e81f65-45dd-4025-a4f2-4ad66bd4da9c

> FDA 483 for Alcami Carolinas Corporation on October 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Carolinas Corporation
- Inspection Date: 2021-10-29
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Alcami Carolinas Corporation in Charleston, SC, a drug manufacturer, revealed four significant observations. The firm was cited for inadequate validation of sterilization processes, failure to calibrate instruments at suitable intervals, not following test procedures for pyrogens, and improper handling of microbial identification samples. These issues indicate deficiencies in the firm's quality control and manufacturing practices for sterile drug products.

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

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