FDA Inspection 1307498 - R2 Digital Milling Technologies Inc. - March 12, 2026

FDA Inspection 1307498 for R2 Digital Milling Technologies Inc. on March 12, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1307498 for R2 Digital Milling Technologies Inc. on March 12, 2026. Classification: N/A.

Violation Codes

21 CFR 801.20(a)

21 CFR 830.300(a)

ISO 13485:2016 Clause 4.2.4

ISO 13485:2016 Clause 7.1

ISO 13485:2016 Clause 7.3.8

ISO 13485:2016 Clause 7.4.1

ISO 13485:2016 Clause 7.5.1

ISO 13485:2016 Clause 7.5.6

ISO 13485:2016 Clause 8.2.2

ISO 13485:2016 Clause 8.2.4

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Record Information

Company

R2 Digital Milling Technologies Inc.

Inspection Date

March 12, 2026

Product Type

Medical Devices & Rad Health

Office

New Jersey District Office

ID: 0d89873c-b8e1-4932-848b-f0a34c2fbe94

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