MDR Violations Merit Company an FDA Warning Letter

The FDA’s recent Warning Letter to Augustine Temperature Management focused on a single — issue problems with medical device reporting (MDR) — citing the Bloomington, Minn.,-based company for multiple failures to adequately develop, maintain and implement written MDR procedures.

Augustine, which makes class II patient warming devices, received an FDA Form 483 following an inspection Sept. 9-16, 2023, and the FDA said in the Warning Letter that it found the company’s response to the 483 inadequate.

Said the agency, during the inspection, an investigator read the company’s “Vigilance and MDR Reporting Procedure” and found that the company had not established internal systems that result in timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements.

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