# FDA 483 - FUJIFILM Wako Chemicals U.S.A. Corporation - September 27, 2018

Source: https://www.keypedia.com/records/483/fujifilm-wako-chemicals-usa-corporation/325077ee-2d71-43ba-8a61-0126460813e8

> FDA 483 for FUJIFILM Wako Chemicals U.S.A. Corporation on September 27, 2018. 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: 2018-09-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of FUJIFILM Wako Chemicals U.S.A. in Richmond, VA, a licensed in-vitro diagnostic device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate maintenance of device history records, lack of control over non-conforming products, and insufficient validation of quality system software. The findings indicate a need for improved documentation, procedural controls, and environmental monitoring to ensure product quality and regulatory compliance.

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- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e