FDA Inspection
Elevate Oral CareElevate Oral Care – FDA Inspection, Aug 28, 2015
Record Details
This FDA Inspection record concerns Elevate Oral Care, with an inspection on August 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elevate Oral Care
- Inspection Date
- August 28, 2015
- Product Type
- Devices
View Company Profile
ID · 400e2f56-36f5-47f4-91f3-7c0d07e93986
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941446
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elevate Oral Care
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2025 | Not classified | Florida District Office | |
| May 15, 2025 | Not classified | Florida District Office | |
| September 7, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 6, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Elevate Oral Care
- FDA Inspection 1285290 - 2025-09-16
- FDA Inspection 1271193 - 2025-05-15
- FDA Inspection 1218722 - 2023-09-07
- FDA Inspection 1101266 - 2019-09-06
- FDA Inspection 1031595 - 2017-11-17
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