Drug factory · FDA FEI 3010002722
Keystone Industries
480 South Democrat Road, Gibbstown, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2013: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aluminum Cation | Makes it and labels it | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 68400-203 |
| Benzocaine | Makes it and labels it | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 68400-501 |
| Fluoride Ion | Makes it and labels it | DMG America, LLC, Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 25047-771, 25047-772, 25047-773 +21 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 21, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 5, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 6, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 7, 2025 inspection
- Component identity verification 21 CFR 211.84(d)(1)
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Dec 21, 2022 inspection
- Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 7, 2018 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Rejecting When Specifications Not Met 21 CFR 211.84(e)
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Apr 5, 2016 inspection
- Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established specifications are not rejected.
Registered with FDA for: label; manufacture; pack.