FDA Inspection
HeartStitch, Inc.HeartStitch, Inc. – FDA Inspection, Jun 25, 2025
Record Details
This FDA Inspection record concerns HeartStitch, Inc., with an inspection on June 25, 2025, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · bc92d4a2-d939-4df5-9dd0-5ee9eef94ac5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1273782
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HeartStitch, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 10, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HeartStitch, Inc.
- FDA Inspection 1102896 - 2019-08-29
- FDA Inspection 847848 - 2013-09-10
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