FDA Inspection
MyCareTeam, Inc.MyCareTeam, Inc. – FDA Inspection, Nov 13, 2012
Record Details
This FDA Inspection record concerns MyCareTeam, Inc., with an inspection on November 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MyCareTeam, Inc.
- Inspection Date
- November 13, 2012
- Product Type
- Devices
View Company Profile
ID · 485b5f4f-5f06-496b-a098-e9d8306ab064
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808213
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.180Availability
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Other FDA inspections of MyCareTeam, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MyCareTeam, Inc.
- FDA Inspection 630584 - 2009-11-10
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