# FDA 483 - FUJIFILM Healthcare Americas Corporation - July 02, 2019

Source: https://www.globalkeysolutions.net/records/483/fujifilm-healthcare-americas-corporation/66a3154e-a133-43af-b37d-f36733e1a0e8

> FDA 483 for FUJIFILM Healthcare Americas Corporation on July 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Healthcare Americas Corporation
- Inspection Date: 2019-07-02
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Fujifilm Medical Systems U.S.A., Inc. in Wayne, NJ, was inspected regarding its complaint file establishment. The inspection revealed deficiencies in the firm's complaint handling procedures, specifically regarding the closure of complaint investigations and the documentation of decisions not to report potential Medical Device Reports (MDRs). These issues indicate a lack of adherence to established internal procedures for record-keeping and decision deliberation.

## Related Documents

- [WARNING_LETTER - 2015-05-01](https://www.globalkeysolutions.net/records/warning_letter/fujifilm-healthcare-americas-corporation/e024b9ff-36ce-43ac-a32d-ca1daf1e1104)
- [483 - 2015-04-09](https://www.globalkeysolutions.net/records/483/fujifilm-healthcare-americas-corporation/5cc6c822-733a-4cfe-ab84-4f17fa678e9b)

## Related Officers

- [William R. Chang](https://www.globalkeysolutions.net/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.globalkeysolutions.net/companies/fujifilm-healthcare-americas-corporation/2e493068-8e15-45e6-b777-5a484d761611

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248