# FDA 483 - Tactical Medical Solutions LLC - December 10, 2021

Source: https://www.globalkeysolutions.net/records/483/tactical-medical-solutions-llc/5dc47c7c-c766-4d7d-8e5d-abc7231fab2c

> FDA 483 for Tactical Medical Solutions LLC on December 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tactical Medical Solutions LLC
- Inspection Date: 2021-12-10
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Tactical Medical Solutions LLC, a medical device manufacturer in Anderson, SC, was cited for three observations during an FDA inspection from December 6-10, 2021. The firm failed to establish quality agreements with suppliers, did not document equipment calibrations, and had inadequate procedures and documentation for receiving acceptance activities for their tourniquet products. These issues indicate significant deficiencies in their quality system.

## Related Officers

- [Miaja Umaedi](https://www.globalkeysolutions.net/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)
- [issuing_officer](https://www.globalkeysolutions.net/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.globalkeysolutions.net/companies/tactical-medical-solutions-llc/eb4ba6ce-9eda-4b45-af7f-25b57efb993b

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