# FDA 483 - Olympus Medical Systems Corporation - September 09, 2022

Source: https://www.globalkeysolutions.net/records/483/olympus-medical-systems-corporation/ae9bbd00-cda2-496b-8b7f-fb0767255b64

> FDA 483 for Olympus Medical Systems Corporation on September 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olympus Medical Systems Corporation
- Inspection Date: 2022-09-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Olympus Medical Systems Corporation, a specification developer in Hachioji-shi, Tokyo, was cited for failing to submit Medical Device Reports (MDRs) within the required 30-day timeframe. The inspection revealed 37 late MDR submissions for its Cysto-Nephro Scope and Uretero-Reno Scope product families. This issue is a recurring observation, indicating a persistent problem with timely reporting of adverse events.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/olympus-medical-systems-corporation/379fd9bd-61c8-414d-b11c-b129dea1aa8b)
- [WARNING_LETTER - 2022-09-09](https://www.globalkeysolutions.net/records/warning_letter/olympus-medical-systems-corporation/d550110d-d64f-4e50-a9f0-9789112f6ab5)

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/olympus-medical-systems-corporation/85e505c8-f012-4c6c-bce6-67e3879f0d01

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd