FDA Inspection
SPS Medical Supply CorporationSPS Medical Supply Corporation – FDA Inspection, Jul 17, 2017
Record Details
This FDA Inspection record concerns SPS Medical Supply Corporation, with an inspection on July 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 94942a03-3789-4979-b562-6c9ea3a49664
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1018239
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SPS Medical Supply Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SPS Medical Supply Corporation
- FDA Inspection 910603 - 2015-01-16
- FDA Inspection 888902 - 2014-07-23
- FDA Inspection 704348 - 2010-12-16
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