FDA Inspection
Elevate Oral CareElevate Oral Care – FDA Inspection, Sep 6, 2019
Record Details
This FDA Inspection record concerns Elevate Oral Care, with an inspection on September 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6c10bc71-d23e-4628-b0d5-11bd6980cc01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101266
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.192Written record of investigation incomplete
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 |
| November 17, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 28, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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 1031595 - 2017-11-17
- FDA Inspection 941446 - 2015-08-28
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