# FDA 483 - Inventex Medical - September 13, 2023

Source: https://www.keypedia.com/records/483/inventex-medical/3f04e765-7356-4881-aeec-a68b7ad56337

> FDA 483 for Inventex Medical on September 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inventex Medical
- Inspection Date: 2023-09-13
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Inventex Medical in Niles, IL, revealed a significant deficiency in the firm's training procedures. The company failed to adequately establish and follow its own procedures for training and identifying training needs. Specifically, Inventex Medical could not provide documentation of employee training records for several critical assembly operations.

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Company: https://www.keypedia.com/companies/inventex-medical/78ca6456-a93e-47cb-9e0f-2af0fdbad057

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669