FDA Inspection
Bellaire Aesthetics Inc.Bellaire Aesthetics Inc. – FDA Inspection, Jul 22, 2019
Record Details
This FDA Inspection record concerns Bellaire Aesthetics Inc., with an inspection on July 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d2de2e1f-3f66-4162-b993-f2e929e656b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097293
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 803.17Lack of Written MDR Procedures
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