FDA Inspection
Aspen Imaging Healthcare, IncAspen Imaging Healthcare, Inc – FDA Inspection, Aug 19, 2026
Record Details
This FDA Inspection record concerns Aspen Imaging Healthcare, Inc, with an inspection on August 19, 2026, issued by the Dallas District Office, covering medical devices & rad health.
- Inspection Date
- August 19, 2026
- Product Type
- Medical Devices & Rad Health
- Office
- Dallas District Office
- Person
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ID · f910324e-853f-484f-9095-13ea55488751
Inspection Facts
- Inspection number
- 1331626
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.30(a)(2)Results of tests
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 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 6.2(e)Records of personnel competence not maintained
- ISO 13485:2016 Clause 7.3.2Design and development of product not planned and controlled
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
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Other FDA inspections of Aspen Imaging Healthcare, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2023 | Not classified | Dallas District Office |
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