FDA Inspection
Pointcare Technologies, Inc.Pointcare Technologies, Inc. – FDA Inspection, Feb 27, 2012
Record Details
This FDA Inspection record concerns Pointcare Technologies, Inc., with an inspection on February 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pointcare Technologies, Inc.
- Inspection Date
- February 27, 2012
- Product Type
- Devices
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ID · 70c6fc30-87b5-4e9f-92ba-dc5fd7f3f2aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772114
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Showing 10 of 14 citations.
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Other FDA inspections of Pointcare Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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