Drug factory · FDA FEI 3009603151
Elevate Oral Care
346 Pike Rd Suite 1, 5, 13, & 23, West Palm Beach, FL, United States
No problems found at FDA's last inspection, Sep 16, 2025.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2017: 1 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fluoride Ion | Makes it | Elevate Oral Care | 57511-0001, 57511-0002, 57511-0003 +2 |
| Fluoride Ion and Nitrate Ion | Makes it | Elevate Oral Care | 57511-0006, 57511-0503 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 16, 2025 | No problems found | Drug Quality Assurance | — |
| Sep 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 17, 2017 | Serious problems, FDA action | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 6, 2019 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Nov 17, 2017 inspection
- Procedures Written and Followed 21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed. - Expiration date lacking 21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include specimen and copy of labeling. - Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices.
Registered with FDA for: manufacture; relabel; repack.