FDA Inspection
HeartSine Technologies LtdHeartSine Technologies Ltd – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns HeartSine Technologies Ltd, with an inspection on January 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HeartSine Technologies Ltd
- Inspection Date
- January 28, 2011
- Product Type
- Devices
View Company Profile
ID · d3bd7888-7ea2-4a95-a1a1-b8302505a52e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709943
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of HeartSine Technologies Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HeartSine Technologies Ltd
- FDA Inspection 1072134 - 2018-04-12
- FDA Inspection 918076 - 2015-02-12
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