FDA Inspection
SPS Medical Supply CorporationSPS Medical Supply Corporation – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns SPS Medical Supply Corporation, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7568fbe8-0dec-4f21-a5af-9d62842105a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065549
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of SPS Medical Supply Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SPS Medical Supply Corporation
- FDA Inspection 812390 - 2012-12-20
- FDA Inspection 707071 - 2011-01-21
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