FDA Inspection
Sterile Processing Services of America (SPSA)Sterile Processing Services of America (SPSA) – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Sterile Processing Services of America (SPSA), with an inspection on June 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 10, 2010
- Product Type
- Devices
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ID · dc9c25db-c7c6-4949-bf73-ae12cb893539
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666527
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Sterile Processing Services of America (SPSA)
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterile Processing Services of America (SPSA)
- FDA Inspection 1062129 - 2018-06-28
- FDA Inspection 906582 - 2014-11-18
- FDA Inspection 899497 - 2014-10-09
- FDA Inspection 754431 - 2011-11-18
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