# FDA 483 - Fujifilm Corporation - September 22, 2023

Source: https://www.keypedia.com/records/483/fujifilm-corporation/e6d1516f-a0ee-4183-b144-fb1dd013eafa

> FDA 483 for Fujifilm Corporation on September 22, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fujifilm Corporation
- Inspection Date: 2023-09-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Fujifilm Corporation, a medical device manufacturer in Ashigarakami-Gun, Japan, was cited for three observations during an FDA inspection. The firm failed to adequately establish corrective and preventive action procedures, including missing documentation for design transfers and complaint reviews. Additionally, the company submitted Medical Device Reports (MDRs) with incomplete information, specifically regarding the manufacturing site and patient identifiers.

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## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/fujifilm-corporation/6310bc48-89ef-4f36-98c9-1e0294a89e06

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