# FDA 483 - Guy & O'Neill Inc. - August 22, 2019

Source: https://www.keypedia.com/records/483/guy-oneill-inc/a3eac6be-0fea-45a9-9d59-3727a06fe90a

> FDA 483 for Guy & O'Neill Inc. on August 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guy & O'Neill Inc.
- Inspection Date: 2019-08-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Guy F. O'Neill Inc., a medical device manufacturer in Fredonia, WI, was cited with six observations during an FDA inspection from August 5-22, 2019. The inspection revealed significant deficiencies in design control, stability study documentation, sampling plans, non-conforming product control, corrective and preventive actions, and medical device reporting procedures. These issues indicate a systemic lack of adequate quality system procedures and adherence to established protocols for medical device manufacturing.

## Related Documents

- [483 - 2021-10-29](https://www.keypedia.com/records/483/guy-oneill-inc/0004b4c5-2e7c-4f89-8197-58d145330f10)

## Related Officers

- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/guy-oneill-inc/786b6282-4f9d-4f5d-8752-6f612ed5fc24

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d