FDA Inspection
Sendx Medical IncSendx Medical Inc – FDA Inspection, Jan 20, 2009
Record Details
This FDA Inspection record concerns Sendx Medical Inc, with an inspection on January 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sendx Medical Inc
- Inspection Date
- January 20, 2009
- Product Type
- Devices
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ID · df27ac09-afbb-4182-90ea-0c8306fcde67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 557428
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.70(b)Production and process changes - failure to follow procedure
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.250(b)Sampling plans
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sendx Medical Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sendx Medical Inc
- FDA Inspection 1295680 - 2025-12-04
- FDA Inspection 1174815 - 2022-06-29
- FDA Inspection 1031157 - 2017-10-31
- FDA Inspection 898205 - 2014-09-29
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