FDA Inspection
Elevate Oral CareElevate Oral Care – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Elevate Oral Care, with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8cf338de-9b00-45c6-aa55-aafc25027ecd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1031595
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
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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 |
| 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 1101266 - 2019-09-06
- FDA Inspection 941446 - 2015-08-28
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