FDA Inspection
Aspire Bariatrics LLCAspire Bariatrics LLC – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Aspire Bariatrics LLC, with an inspection on August 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e34fb290-5510-4ba7-9792-619ff78fd9ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024937
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Aspire Bariatrics LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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