FDA Inspection
Pointcare Technologies, Inc.Pointcare Technologies, Inc. – FDA Inspection, Apr 28, 2011
Record Details
This FDA Inspection record concerns Pointcare Technologies, Inc., with an inspection on April 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pointcare Technologies, Inc.
- Inspection Date
- April 28, 2011
- Product Type
- Devices
View Company Profile
ID · ecaee8fb-603d-44d8-925c-7a0d05da2c36
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 723738
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 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 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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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 |
| February 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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