FDA Inspection
Pinook USA, LLCPinook USA, LLC – FDA Inspection, Feb 24, 2012
Record Details
This FDA Inspection record concerns Pinook USA, LLC, with an inspection on February 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pinook USA, LLC
- Inspection Date
- February 24, 2012
- Product Type
- Devices
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ID · e514038e-cceb-459f-80ee-1469741d2900
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 769446
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pinook USA, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 1, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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