FDA Inspection
Kale Research & TechnologyKale Research & Technology – FDA Inspection, Aug 26, 2009
Record Details
This FDA Inspection record concerns Kale Research & Technology, with an inspection on August 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kale Research & Technology
- Inspection Date
- August 26, 2009
- Product Type
- Devices
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ID · c2797198-b7f2-4ec0-8dfa-eae3b47f5441
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 613365
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(b)Establish the design and development plan
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Other FDA inspections of Kale Research & Technology
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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