FDA Inspection
Pandah Co.Pandah Co. – FDA Inspection, May 17, 2016
Record Details
This FDA Inspection record concerns Pandah Co., with an inspection on May 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pandah Co.
- Inspection Date
- May 17, 2016
- Product Type
- Devices
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ID · ec13e649-df1e-47ed-b333-5effeba61bef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971396
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Pandah Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pandah Co.
- FDA Inspection 796416 - 2012-08-29
- FDA Inspection 613960 - 2009-09-21
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