# FDA WARNING_LETTER - Northern Digital Inc. - March 28, 2013

Source: https://www.keypedia.com/records/warning_letter/northern-digital-inc/3aafa020-8203-4059-b952-ff85f50e3018

> FDA WARNING_LETTER for Northern Digital Inc. on March 28, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Northern Digital Inc.
- Inspection Date: 2013-03-28
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 24, 2013, the FDA issued a Warning Letter to Northern Digital, Inc. (NDI) following a March 25-28, 2013, inspection of their Waterloo, ON facility, which manufactures Reflective Passive Marker Spheres for Image Guided Surgical Systems. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include:
1.  **Process Validation (21 CFR 820.75(a)):** Failure to validate the sphere manufacturing process, especially after relocation to Mexico in 2009. IQ/OQ/PQ was not performed during the relocation or prior manufacturing in Waterloo. Corrective actions are ongoing, including a retrospective review, CAPA CAR157, and audits of the contract manufacturer, with a target completion by August 30, 2013.
2.  **Design Verification (21 CFR 820.30

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/northern-digital-inc/a193a16c-d083-4627-ac64-e779796715e5

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7