# FDA 483 - Access Point Technologies - December 20, 2022

Source: https://www.globalkeysolutions.net/records/483/access-point-technologies/6be2a62a-15ca-495f-9f00-b8703b9c5057

> FDA 483 for Access Point Technologies on December 20, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Access Point Technologies
- Inspection Date: 2022-12-20
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Access Point Technologies in Rogers, MN, a medical device manufacturer, identified significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for monitoring validated process parameters, resulting in non-conforming product without appropriate corrective action. Additionally, procedures for in-process product acceptance were not properly implemented, leading to concerns about data integrity and a lack of rejection for out-of-specification materials.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/access-point-technologies/a59bb412-c7cb-4825-b925-eed9ed738136

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