Company
United StatesHeartsine Technologies Inc, Newtown, PA – FDA Inspections
Inspection records and compliance data for Heartsine Technologies Inc in Newtown, Pennsylvania. 5 FDA inspections on record (2 OAI), 1 warning letter, last inspected May 03, 2018.
Company Profile
This profile covers Heartsine Technologies Inc based in Newtown, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 1
First inspected August 4, 2009. Last inspected May 3, 2018.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 3, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1068673 |
| September 16, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 897171 |
| August 22, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 847671 |
| March 16, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 652945 |
| August 4, 2009 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 601913 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Heartsine Technologies Inc
FEI Number
3004018643
Address
121 Friends Ln Ste 400, Newtown, Pennsylvania 18940, United States
Country
United States
ID: be932741-f273-49ae-a309-933fdaa1d098