Argon Medical Productions & Vertrieb Gesellschaft MBH & CO

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 review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or package to meet any of its specification unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c). For example:

Passage 2

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a). For example, during the inspection, your firm acknowledged the procedure Post Market Surveillance procedure A002 as its written MDR procedure, and agreed with the investigator that the procedure have the following deficiencies:

Passage 3

Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).