Augustine Temperature Management, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm identified the document titled “Vigilance and MDR Reporting Procedure”, Doc# D1041, Rev. N, dated 8/17/2023 as its written MDR procedure. After reviewing the procedure, the following deficiencies were noted:

Passage 2

Failure to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

Passage 3

Failure to submit a Report of Correction or Removal of a device initiated to reduce a risk to health posed by the device, as required by 21 CFR Part 806.10.

Passage 4

Failure to document the acceptance or rejection of incoming product, as required per 21 CFR 820.80(b). Specifically, multiple incoming component inspection records could not be located upon inspectional requests. For example, inspection records were not available for review for the following incoming components: