# FDA 483 - Augustine Temperature Management, LLC - November 27, 2024

Source: https://www.keypedia.com/records/483/augustine-temperature-management-llc/ffa55b17-53ed-47df-9e46-5120450dc966

> FDA 483 for Augustine Temperature Management, LLC on November 27, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Augustine Temperature Management, LLC
- Inspection Date: 2024-11-27
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Augustine Temperature Management, LLC, a medical device manufacturer in Minnetonka, MN, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures to report device corrections and adverse events (MDRs), inadequate finished device acceptance procedures, and deficiencies in both corrective and preventive action and design validation processes. These issues indicate a lack of adherence to established quality system regulations, potentially impacting device safety and effectiveness.

## Related Documents

- [483 - 2023-09-19](https://www.keypedia.com/records/483/augustine-temperature-management-llc/1851a683-dfd3-4423-be11-5f77a3e3c5b0)
- [WARNING_LETTER - 2023-09-19](https://www.keypedia.com/records/warning_letter/augustine-temperature-management-llc/71655304-4222-4f52-8c8e-4233ee124497)

## Related Officers

- [Alicia U. Jacobo](https://www.keypedia.com/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

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