FDA Inspection
Medical Acoustics, LLCMedical Acoustics, LLC – FDA Inspection, Dec 6, 2017
Record Details
This FDA Inspection record concerns Medical Acoustics, LLC, with an inspection on December 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ab88c223-3f16-40fa-9c65-c703d4b4ecdd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034250
- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Medical Acoustics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Acoustics, LLC
- FDA Inspection 1115542 - 2020-01-16
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