Company
United StatesHeartStitch, Inc., Fountain Valley, CA – FDA Inspections
Inspection records and compliance data for HeartStitch, Inc. in Fountain Valley, California. 3 FDA inspections on record, 1 Form 483, last inspected June 25, 2025.
Company Profile
This profile covers HeartStitch, Inc. based in Fountain Valley, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected September 10, 2013. Last inspected June 25, 2025.
Most cited issue areas
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 25, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1273782 |
| August 29, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1102896 |
| September 10, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 847848 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
HeartStitch, Inc.
FEI Number
3009142291
Address
17074 Newhope St, Fountain Valley, California 92708, United States
Country
United States
ID: c4b688fa-d6bd-4b35-9c6f-ded4a89407ad