FDA Inspection
Aesthetics Biomedical, Inc.Aesthetics Biomedical, Inc. – FDA Inspection, Jan 21, 2020
Record Details
This FDA Inspection record concerns Aesthetics Biomedical, Inc., with an inspection on January 21, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aesthetics Biomedical, Inc.
- Inspection Date
- January 21, 2020
- Product Type
- Devices
View Company Profile
ID · e5941ff0-9751-4c79-9590-b89823fec7a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115562
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Aesthetics Biomedical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aesthetics Biomedical, Inc.
- FDA Inspection 1047470 - 2018-03-15
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