Company
United KingdomHeartSine Technologies Ltd, Belfast, United Kingdom – FDA Inspections
Inspection records and compliance data for HeartSine Technologies Ltd in Belfast. 3 FDA inspections on record, last inspected April 12, 2018.
Company Profile
This profile covers HeartSine Technologies Ltd based in Belfast, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 28, 2011. Last inspected April 12, 2018.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1072134 |
| February 12, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 918076 |
| January 28, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 709943 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
HeartSine Technologies Ltd
FEI Number
3004123209
Address
207 Airport Road West, Belfast, United Kingdom
Country
United Kingdom
ID: 63b59bad-1cb6-4984-811a-77a04c299dd6