FDA Inspection
Emerge Technologies IncEmerge Technologies Inc – FDA Inspection, Apr 24, 2026
Record Details
This FDA Inspection record concerns Emerge Technologies Inc, with an inspection on April 24, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 02638bf0-d056-4a64-a2cc-cc3a70276c25
Inspection Facts
- Inspection number
- 1313776
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
- ISO 13485:2016 Clause 4.2.1Quality management system documentation not adequate
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 6.2Process(es) for personnel competence, training and awareness not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
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