Drug factory · FDA FEI 3009607669
Cimbar Performance Minerals, Inc.
1501 Old Federal Road North, Chatsworth, GA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 18, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Barium | Makes the active ingredient | E-Z-EM Canada Inc | 32909-764 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 18, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 30, 2020 | No problems found | Drug Quality Assurance | — |
| Feb 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 30, 2015 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 3, 2017 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance. - Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not conduct an investigation when necessary. - Thorough investigations 21 CFR 606.100(c)
Failure to perform a thorough investigation of a failure of a lot or unit to meet any of its specifications.
Registered with FDA for: api manufacture.