# FDA 483 - MEDTRONIC GRAND RAPIDS - December 15, 2025

Source: https://www.keypedia.com/records/483/medtronic-grand-rapids/5c90c3da-68fc-4323-a8b1-9bd8788c0325

> FDA 483 for MEDTRONIC GRAND RAPIDS on December 15, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDTRONIC GRAND RAPIDS
- Inspection Date: 2025-12-15
- Product Type: devices
- Office Name: Detroit District Office
- Summary: From December 8 to December 15, 2025, the FDA conducted an inspection of the Medtronic Grand Rapids manufacturing facility in Michigan. The inspection resulted in a Form 483 detailing two primary areas of concern regarding the facility’s adherence to the Federal Food, Drug, and Cosmetic Act: inadequate environmental controls and insufficient corrective action procedures.

Investigators observed several failures within the clean room operations. Specifically, the facility failed to escalate an incident where clean room air change rates did not meet established safety specifications, potentially risking product contamination. Furthermore, the firm’s environmental risk assessments were found to be generic and incomplete, failing to account for different room layouts or provide mitigation strategies for identified high-risk hazards. Personnel practices were also cited, including inadequate gowning area protocols and staff members failing to follow hygiene procedures after touching their faces in sterile environments.

Additionally, the firm’s Corrective and Preventive Action (CAPA) system was found to be ineffective. The facility did not initiate formal investigations or systemic corrections despite documented trends of microbiological contamination. There was also no objective evidence that management performed the required periodic reviews of environmental monitoring data. While the Site Director has promised to correct these deficiencies, the company is expected to implement rigorous quality system oversight and submit a formal response to the FDA outlining their remedial actions.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)
- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/medtronic-grand-rapids/1863d548-4a7c-4559-816b-991360c608f4

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03