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Device establishmentActive, RegisteredFDA warning letter on file

Augustine Temperature Management, LLC

Augustine Temperature Management, LLC is an FDA-registered device establishment (FEI 3005857264) located in Minnetonka, Minnesota. The facility is active, registered. Its most recent FDA inspection on record (2024-11-27) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 21, 2024
Medical Device Reporting/Misbranded
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

Mar 14, 2022 Class II
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
CompletedView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3005857264
Address
15305 Minnetonka Blvd, Minnetonka, Minnesota
Establishment type
Device establishment
Products / operations
Cardiovascular, Develop Specifications But Do Not Manufacture At This Facility, Manufacture Medical Device, General, Plastic Surgery, Anesthesiology
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Nov 27, 2024 · Official Action Indicated (OAI)
Sep 19, 2023 · Official Action Indicated (OAI)
Jan 4, 2017 · Voluntary Action Indicated (VAI)
Sep 26, 2012 · No Action Indicated (NAI)
Jul 14, 2010 · Voluntary Action Indicated (VAI)
Form 483 observations
Nov 27, 2024, 5 observations: Lack of or inadequate final acceptance procedures; Report of Death or Serious Injury; Report of risk to health
Sep 19, 2023, 2 observations: Lack of or inadequate procedures; Incoming acceptance records, documentation
Jan 4, 2017, 3 observations: Investigation of device failures; Nonconforming product, Lack of or inadequate procedures; Lack of or inadequate complaint procedures
Jul 14, 2010, 7 observations: Product rework documentation, DHR {see also 820.184}; Design verification - output does not meet input requirement; Documentation

FDA record timeline

FDA inspection
OAI classification
Form 483
5 observations
Warning letter
Medical Device Reporting/Misbranded
Source ›
FDA inspection
OAI classification
Form 483
2 observations
Recall
Class II — HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Source ›
FDA inspection
VAI classification
Form 483
3 observations
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
7 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is Augustine Temperature Management, LLC registered with the FDA?

Yes. Augustine Temperature Management, LLC is an FDA-registered device establishment (FEI 3005857264) in Minnetonka, Minnesota. Its current registration status is Active, Registered.

Has Augustine Temperature Management, LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Augustine Temperature Management, LLC; the most recent is dated Mar 21, 2024 (Medical Device Reporting/Misbranded).

What does Augustine Temperature Management, LLC do?

Augustine Temperature Management, LLC's FDA-registered operations are: Cardiovascular, Develop Specifications But Do Not Manufacture At This Facility, Manufacture Medical Device, General, Plastic Surgery, Anesthesiology.

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Source: FDA public data · status as of 2026-08-22

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