FDA Inspection
Impladent Ltd.Impladent Ltd. – FDA Inspection, Oct 29, 2009
Record Details
This FDA Inspection record concerns Impladent Ltd., with an inspection on October 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Impladent Ltd.
- Inspection Date
- October 29, 2009
- Product Type
- Devices
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ID · 80c25349-ffe6-454e-ae5d-d1d2d3831a9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 625455
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Impladent Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2025 | Not classified | New York District Office | |
| October 11, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Impladent Ltd.
- FDA Inspection 1261471 - 2025-02-19
- FDA Inspection 1068877 - 2018-10-11
- FDA Inspection 953515 - 2015-11-12
- FDA Inspection 947769 - 2015-11-05
- FDA Inspection 855776 - 2013-11-12
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