FDA Inspection
Livermoretech, Inc.Livermoretech, Inc. – FDA Inspection, Aug 14, 2026
Record Details
This FDA Inspection record concerns Livermoretech, Inc., with an inspection on August 14, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · f6727231-8380-47ea-bbaf-e2cba9ed4793
Inspection Facts
- Inspection number
- 1284322
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.30(a)(2)Results of tests
- 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 5.6.1QMS not reviewed by top management at documented planned intervals
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
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Other FDA inspections of Livermoretech, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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