# FDA 483 - FUJIFILM Wako Chemicals U.S.A. Corporation - May 10, 2024

Source: https://www.keypedia.com/records/483/fujifilm-wako-chemicals-usa-corporation/42037290-7bd3-4be1-bb50-37bea011030d

> FDA 483 for FUJIFILM Wako Chemicals U.S.A. Corporation on May 10, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Wako Chemicals U.S.A. Corporation
- Inspection Date: 2024-05-10
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of FUJIFILM Wako Chemicals U.S.A. Corporation in Richmond, VA, revealed significant deficiencies in their manufacturing processes for IVD products. Observations included inadequate control and monitoring of production, failures in equipment calibration and maintenance, and issues with device history record documentation. These findings indicate a lack of adherence to established quality system procedures.

## Related Documents

- [483 - 2018-09-27](https://www.keypedia.com/records/483/fujifilm-wako-chemicals-usa-corporation/325077ee-2d71-43ba-8a61-0126460813e8)

## Related Officers

- [Nisha C. Patel](https://www.keypedia.com/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)
- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)
- [FDA_PERSONNEL](https://www.keypedia.com/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)

Company: https://www.keypedia.com/companies/fujifilm-wako-chemicals-usa-corporation/f3897ce4-a5ce-4ca2-99c3-1614b23e6123

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64