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

Source: https://www.keypedia.com/records/483/medtronic-grand-rapids/cd69304f-4b6c-46f7-8e02-7cced9a27023

> FDA 483 for MEDTRONIC GRAND RAPIDS on December 15, 2025. Product: device. 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: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Medtronic Grand Rapids, a medical device manufacturer, revealed significant deficiencies in environmental control procedures and the corrective and preventive action (CAPA) system. Observations included an unqualified clean room with an out-of-specification air change rate, inadequate and incomplete risk assessments for clean rooms, and improper personnel gowning and hygiene practices. Furthermore, the firm failed to escalate microbiological nonconformances into CAPAs and did not adequately document periodic reviews of environmental monitoring data.

## Related Documents

- [483 - 2025-12-15](https://www.keypedia.com/records/483/medtronic-grand-rapids/5c90c3da-68fc-4323-a8b1-9bd8788c0325)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0