FDA Inspection
Bedfont Scientific, Ltd.Bedfont Scientific, Ltd. – FDA Inspection, Sep 10, 2015
Record Details
This FDA Inspection record concerns Bedfont Scientific, Ltd., with an inspection on September 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bedfont Scientific, Ltd.
- Inspection Date
- September 10, 2015
- Product Type
- Devices
View Company Profile
ID · 8f2263c9-918b-4790-b36f-f20a9fbae04f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 944304
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bedfont Scientific, Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bedfont Scientific, Ltd.
- FDA Inspection 1108098 - 2019-10-31
- FDA Inspection 975463 - 2016-06-14
- FDA Inspection 744835 - 2011-08-25
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