# FDA 483 - AbleNet, Inc. - July 08, 2024

Source: https://www.keypedia.com/records/483/ablenet-inc/3e40c495-b4a5-4e19-8e72-5f5488a8fece

> FDA 483 for AbleNet, Inc. on July 08, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AbleNet, Inc.
- Inspection Date: 2024-07-08
- Product Type: devices
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of AbleNet, Inc., a medical device manufacturer, was conducted from June 26 to July 8, 2024. The inspection revealed eight significant deficiencies in the company's quality management system, falling under the regulatory framework of the FDA's Quality System Regulation (21 CFR Part 820).

Several critical issues were repeat observations from a prior 2017 inspection, indicating persistent non-compliance. These included the absence of established procedures for corrective and preventive actions (CAPA), inadequate systems for receiving and evaluating customer complaints (including adverse event determination), and the failure to implement procedures for quality audits and management review of the quality system. Furthermore, Medical Device Reporting (MDR) procedures were not adequately developed, specifically lacking comprehensive adverse event definitions and electronic reporting provisions.

Additional observations cited the lack of established purchasing controls, with unapproved suppliers and unspecified quality requirements for device components. The firm also lacked effective procedures for controlling nonconforming products, as evidenced by unsegregated scrap materials. Lastly, training procedures were deemed insufficient, relying on general job descriptions and undocumented, informal training methods, failing to ensure personnel are adequately qualified for their tasks.

AbleNet, Inc. is required to promptly establish, document, and effectively implement comprehensive procedures to address all identified deficiencies, particularly the repeat observations, to ensure the quality and safety of their manufactured medical devices.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)
- [Alicia U. Jacobo](https://www.keypedia.com/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)
- [CEO](https://www.keypedia.com/people/jennifer-l-thalhuber/b90d396d-0c07-417b-8617-768119a54100)

Company: https://www.keypedia.com/companies/ablenet-inc/ab4523e3-ec2f-4c11-bad3-e8f12ea8db53

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