FDA Inspection
Lifesync CorporationLifesync Corporation – FDA Inspection, Jan 11, 2012
Record Details
This FDA Inspection record concerns Lifesync Corporation, with an inspection on January 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lifesync Corporation
- Inspection Date
- January 11, 2012
- Product Type
- Devices
View Company Profile
ID · 79dd193a-a44a-4a29-8fb3-d689b98be1ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 763668
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 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 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Lifesync Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lifesync Corporation
- FDA Inspection 935425 - 2015-07-24
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