# FDA 483 - Instrumed International Inc - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/instrumed-international-inc/7468de7f-b2c2-4b8a-87c7-51c166f5edd5

> FDA 483 for Instrumed International Inc on December 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Instrumed International Inc
- Inspection Date: 2023-12-05
- Product Type: device
- Office Name: Chicago District Office
- Summary: Instrumed International Inc, a contract manufacturer/repackager/relabeller in Schaumburg, IL, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection cited inadequate procedures for ensuring purchased product conformity, establishing and closing corrective and preventive actions, and documenting CAPA activities. Additionally, the firm lacked proper documentation availability and failed to establish adequate procedures for reworking nonconforming products.

## Related Officers

- [Brittani N. Franklin](https://www.globalkeysolutions.net/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.globalkeysolutions.net/companies/instrumed-international-inc/716286b3-25b2-4131-a341-a33f35ca4ac7

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