Fresenius Kabi AG

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 establish procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100(a). Specifically, your CORRECTIVE AND PREVENTIVE PROCEDURE, Doc.ID: 410-0013-01, Revisions 12, 13, and 14, are inadequate in that:

Passage 2

Failure to establish procedures for validating the device design and failure to include software validation and risk analysis, where appropriate, as required by 21 CFR § 820.30(g). Specifically, your risk analysis is inadequate in that it was not updated as required per Risk Management Procedure, 410-0009-01, Revision: 17.

Passage 3

Failure to report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR § 803.50(a)(2).

Passage 4

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR § 803.17. For example, during the inspection, your firm presented the following documents:

Passage 5

Failure to submit a correction or removal initiated to reduce a risk to health posed by the device and required to be reported to the FDA by 21 CFR § 806.10(a), was not reported in writing within 10-working days of initiating such correction or removal, as required by 21 CFR § 806.10(b).