FDA Inspection
American Aesthetics Medical Supply, Inc.American Aesthetics Medical Supply, Inc. – FDA Inspection, Nov 13, 2012
Record Details
This FDA Inspection record concerns American Aesthetics Medical Supply, Inc., with an inspection on November 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 13, 2012
- Product Type
- Devices
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ID · 76332ada-3db8-45ad-b034-758b59af82f2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 807450
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of American Aesthetics Medical Supply, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2014 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| March 19, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American Aesthetics Medical Supply, Inc.
- FDA Inspection 902100 - 2014-11-03
- FDA Inspection 823086 - 2013-03-19
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