Medical Devices · Letter issue date: Oct 7, 2026

Olympus Medical Systems Corporation

12 extracted findings

FDA source excerpt, selected passage

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). For example,

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example,

Failure to adequately 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). For example,

Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example,

Failure to ensure that when changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate, as required by 21 CFR 820.75(c). For example,

Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). Specifically,

Failure to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example,

Failure to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example,

Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example,

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. For example,

Failure to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, as required by 21 CFR 820.198(c). For example,

Failure to address any violations of the FD&C Act may result in the FDA refusing admission of the devices manufactured by your firm into the United States under section 801(a) of the FD&C Act, 21 U.S.C. § 381(a). Devices under this authority that appear to be adulterated may be detained or refused admission.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 820.30(g)21 CFR 820.90(a)21 CFR 820.75(a)21 CFR 820.75(b)21 CFR 820.75(c)21 CFR 820.100(a)(3)21 CFR 820.100(a)(4)21 CFR 820.100(a)(1)21 CFR 820.80(b)21 CFR 820.50 21 CFR 820.198(c)21 CFR 803.52 21 CFR 803.12(a)21 CFR 803.50(a)(2)21 CFR 803.321 CFR 80621 CFR 80321 CFR 820

Olympus Medical Systems Corporation

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