Empowered Diagnostics 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 establish and maintain design control procedures in order to ensure that specified design requirements of the device are met, as required by 21 CFR 820.30(a).

Passage 2

Failure to adequately establish and implement corrective and preventive action procedures, as required by 21 CFR 820.100(a).

Passage 3

Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Passage 4

Failure to adequately establish procedures for finished device acceptance, as required by 21 CFR 820.80(d).

Passage 5

Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

Passage 6

Failure to adequately establish and maintain document control procedures, as required by 21 CFR 820.40.