FDA Inspection
R2 Digital Milling Technologies Inc.R2 Digital Milling Technologies Inc. – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns R2 Digital Milling Technologies Inc., with an inspection on March 12, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- March 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 68c363d5-283f-420c-9b31-b9de9001f442
Inspection Facts
- Inspection number
- 1307498
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
11- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.8Design and development transfer procedures not documented
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
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