# FDA 483 - Guy & O'Neill Inc. - October 29, 2021

Source: https://www.keypedia.com/records/483/guy-oneill-inc/0004b4c5-2e7c-4f89-8197-58d145330f10

> FDA 483 for Guy & O'Neill Inc. on October 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guy & O'Neill Inc.
- Inspection Date: 2021-10-29
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Guy & O'Neill Inc. in Fredonia, WI, a manufacturer of personal lubricant, revealed significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for corrective and preventive actions, control of nonconforming products, process validation, storage area control, and internal quality audits. Several observations were repeats from a previous inspection, indicating persistent and systemic issues.

## Related Documents

- [483 - 2019-08-22](https://www.keypedia.com/records/483/guy-oneill-inc/a3eac6be-0fea-45a9-9d59-3727a06fe90a)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-t-domer/8e2d2ff5-b0da-4b0d-bd65-492a49ae1035)
- [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