FDA Inspection
Silhouette Lift, Inc.Silhouette Lift, Inc. – FDA Inspection, Nov 5, 2014
Record Details
This FDA Inspection record concerns Silhouette Lift, Inc., with an inspection on November 5, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Silhouette Lift, Inc.
- Inspection Date
- November 5, 2014
- Product Type
- Devices
View Company Profile
ID · 41b5cecd-0e4b-41b4-b1ac-6555bba58986
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 902550
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Silhouette Lift, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Silhouette Lift, Inc.
- FDA Inspection 1055876 - 2018-06-15
- FDA Inspection 720613 - 2011-03-22
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