O3UV, 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 Register and List

Passage 2

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).

Passage 3

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

Passage 4

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

Passage 5

Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR 820.100(a).

Passage 6

Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).

Passage 7

Failure to establish and maintain procedures to ensure that Device History Records (DHR's) for each batch, lot, or unit are maintained, as required by 21 CFR 820.184.

Passage 8

Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance, as required by 21 CFR 820.22.

Passage 9

Failure of the management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, as required by 21 CFR 820.20(c).