Company
United StatesHeart Smart Inc, Huntington, NY – FDA Inspections
Inspection records and compliance data for Heart Smart Inc in Huntington, New York. 2 FDA inspections on record, 1 Form 483, last inspected February 21, 2017.
Company Profile
This profile covers Heart Smart Inc based in Huntington, New York, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected January 29, 2014. Last inspected February 21, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 21, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1003097 |
| January 29, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 865009 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Heart Smart Inc
FEI Number
3007110919
Address
1160 E Jericho Tpke Ste 204, Huntington, New York 11743, United States
Country
United States
ID: 6aca770f-9d15-4911-aba8-0db748d12357