Drug factory · FDA FEI 2018957
Den-Mat Holdings, LLC dba Clinician's Choice
1017 West Central Ave, Lompoc, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 7, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fluoride Ion | Makes it | Henry Schein, Inc. | 0404-0173 |
| Fluoride Ion and Nitrate Ion | Makes it | Henry Schein, Inc. | 0404-0174 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 7, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 7, 2023 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Registered with FDA for: label; manufacture; pack.