# FDA 483 - Granite Microsystems, Inc. - November 21, 2024

Source: https://www.keypedia.com/records/483/granite-microsystems-inc/45682895-d6e0-481e-b87f-d0dcb1ac519e

> FDA 483 for Granite Microsystems, Inc. on November 21, 2024. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Granite Microsystems, Inc.
- Inspection Date: 2024-11-21
- Product Type: Devices
- Office Name: Minneapolis District Office
- Summary: Granite Microsystems, Inc., a medical device contract manufacturer located in Mequon, WI, underwent an FDA inspection from November 18 to November 21, 2024. The inspection revealed significant compliance issues related to the company's quality control processes.

The primary violation noted was the inadequate establishment of procedures to manage non-conforming products. Specifically, the company's procedure, Control of Non-Conforming Product QP-030, lacks requirements for evaluating nonconformities and conducting necessary investigations. This has resulted in incomplete and inconsistent documentation on Nonconformity Forms, with several forms lacking detailed investigation notes or rationale for corrective actions.

Additionally, the inspection identified a failure to validate processes whose results cannot be fully verified by subsequent inspection and testing. The firm could not provide evidence that its visual inspection process effectively identifies defects, as outlined in its documented criteria.

The FDA has emphasized the importance of Granite Microsystems conducting internal audits to identify and rectify all violations of quality system requirements. The company is expected to address these observations promptly, ensuring that procedures are adequately established and followed to maintain compliance with regulatory standards. Failure to implement corrective actions could lead to further regulatory actions by the FDA.

## Related Documents

- [EIR - 2024-11-21](https://www.keypedia.com/records/eir/granite-microsystems-inc/47220216-746d-47de-8efb-227b7e39db0b)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Chad E. Schmear](https://www.keypedia.com/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)
- [Scott D. Stevens](https://www.keypedia.com/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)
- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)
- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.keypedia.com/companies/granite-microsystems-inc/4aea1ac3-a52b-4198-9ed9-5a8a079bcb55

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