Aizu Olympus Co., Ltd.

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 procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and validation shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).

Passage 2

Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).

Passage 3

Your firm did not state if there are previously distributed devices that were made with specifications that were not validated. Your firm did not provide information on addressing the lack of knowledge of previous curing times and it is unclear how these products meet validation criteria. Your firm’s HHE should address these concerns and determine if a correction or removal is necessary. Your firm should also determine through the HHE whether this issue could have any impact on device reprocessing.

Passage 4

Failure to establish and maintain procedures to ensure that Design History Record (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured accordance with the DMR and the requirements of 21 CFR 820, as required by 21 CFR 820.184.

Passage 5

Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.