# FDA 483 - C-Axis PR., Inc. - October 24, 2024

Source: https://www.globalkeysolutions.net/records/483/c-axis-pr-inc/6bf4a6dd-ff32-4636-af56-df6640056d72

> FDA 483 for C-Axis PR., Inc. on October 24, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C-Axis PR., Inc.
- Inspection Date: 2024-10-24
- Product Type: device
- Office Name: San Juan District Office
- Summary: An FDA inspection of C-Axis PR., Inc., a contract manufacturer in Caguas, PR, revealed two significant issues. The firm failed to adequately establish procedures for the acceptance of incoming product, specifically regarding sample size for inspection. Additionally, procedures for training and identifying training needs were not adequately established, as evidenced by a lack of documentation for employee training in 2023.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/c-axis-pr-inc/506191b4-b878-442d-b0d7-44379c691b7a

Office: https://www.globalkeysolutions.net/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8