# FDA 483 - Richardson Electronics Ltd. - May 26, 2022

Source: https://www.globalkeysolutions.net/records/483/richardson-electronics-ltd/61beb317-b86d-4463-808d-56b011c1ba08

> FDA 483 for Richardson Electronics Ltd. on May 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richardson Electronics Ltd.
- Inspection Date: 2022-05-26
- Product Type: device
- Office Name: Chicago District Office
- Summary: Richardson Imaging System in LaFox, IL was inspected from May 23-26, 2022, regarding its manufacturing of EPRC X-Ray tube housing assemblies. The inspection revealed a significant deficiency in the firm's complaint handling procedures. Specifically, complaint records lacked crucial details, hindering the adequate evaluation of potential medical device reportable events.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/richardson-electronics-ltd/69d46d55-e860-4516-bdf5-2e702793ce61

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669