# FDA 483 - Augustine Temperature Management, LLC - September 19, 2023

Source: https://www.keypedia.com/records/483/augustine-temperature-management-llc/1851a683-dfd3-4423-be11-5f77a3e3c5b0

> FDA 483 for Augustine Temperature Management, LLC on September 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Augustine Temperature Management, LLC
- Inspection Date: 2023-09-19
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Augustine Temperature Management, LLC, a medical device manufacturer in Minneapolis, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including issues with retroactive CAPA creation and ineffective corrective actions for product failures. Additionally, the company lacked proper documentation for the acceptance or rejection of incoming product components.

## Related Documents

- [WARNING_LETTER - 2023-09-19](https://www.keypedia.com/records/warning_letter/augustine-temperature-management-llc/71655304-4222-4f52-8c8e-4233ee124497)
- [483 - 2024-11-27](https://www.keypedia.com/records/483/augustine-temperature-management-llc/ffa55b17-53ed-47df-9e46-5120450dc966)

## Related Officers

- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/augustine-temperature-management-llc/2d889e67-0742-4b94-a656-d2c2f51ed7e4

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d