FDA Inspection
Southeast Aesthetic LTD CoSoutheast Aesthetic LTD Co – FDA Inspection, Nov 6, 2013
Record Details
This FDA Inspection record concerns Southeast Aesthetic LTD Co, with an inspection on November 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Southeast Aesthetic LTD Co
- Inspection Date
- November 6, 2013
- Product Type
- Devices
View Company Profile
ID · f18c8cd1-64f4-499a-8706-4533264f4ed0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855223
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Southeast Aesthetic LTD Co
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Southeast Aesthetic LTD Co
- FDA Inspection 886854 - 2014-07-11
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