FDA Inspection
Strata Skin Sciences, Inc.Strata Skin Sciences, Inc. – FDA Inspection, Sep 24, 2013
Record Details
This FDA Inspection record concerns Strata Skin Sciences, Inc., with an inspection on September 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Strata Skin Sciences, Inc.
- Inspection Date
- September 24, 2013
- Product Type
- Devices
View Company Profile
ID · ca7b11a1-19c5-4c00-92f8-10bde56f28ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.200(d)Service reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Strata Skin Sciences, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 21, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Strata Skin Sciences, Inc.
- FDA Inspection 1229432 - 2024-08-22
- FDA Inspection 1153813 - 2021-09-30
- FDA Inspection 1080043 - 2019-02-21
- FDA Inspection 995149 - 2016-12-16
- FDA Inspection 928601 - 2015-06-16
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