# FDA 483 - Contech Medical, Inc. - August 17, 2023

Source: https://www.keypedia.com/records/483/contech-medical-inc/cf261fc7-21da-4c51-a5f6-4aba7ed9859f

> FDA 483 for Contech Medical, Inc. on August 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contech Medical, Inc.
- Inspection Date: 2023-08-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Contech Medical, Inc., a contract manufacturer in Providence, RI, revealed two significant observations. The firm's procedures for controlling environmental conditions, specifically handling monitoring results and supporting corrective actions, were found to be inadequately established. Additionally, their complaint procedures lacked adequate provisions for reviewing, evaluating, and documenting investigation decisions.

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/contech-medical-inc/136de317-cf1c-4b76-b705-88eda7189723

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961