FDA Inspection
Spaulding Medical LLCSpaulding Medical LLC – FDA Inspection, Apr 4, 2017
Record Details
This FDA Inspection record concerns Spaulding Medical LLC, with an inspection on April 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Richard J. Tucker (Issuing Officer)
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ID · 321ae233-2c6d-4716-a8bf-55c811f6234d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016257
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Spaulding Medical LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 16, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 2, 2017 | Not classified | Minneapolis District Office | |
| October 22, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spaulding Medical LLC
- FDA Inspection 1093447 - 2019-05-31
- FDA Inspection 1070933 - 2018-10-16
- FDA Inspection 1000866 - 2017-02-02
- FDA Inspection 804159 - 2012-10-22
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