Drug factory · FDA FEI 3009143510
3D Imaging Drug Design and Development
9015 CARTI Way, Little Rock, AR, United States
Serious problems, FDA action at FDA's last inspection, Jun 13, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
4 drug inspections on record since 2017: 0 with no problems, 2 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 13, 2025 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jan 31, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Apr 20, 2017 | Serious problems, FDA action | Drug Quality Assurance | 20 |
| Apr 20, 2017 | Problems found, fixed voluntarily | Bioresearch Monitoring | 20 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 31, 2024 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
Apr 20, 2017 inspection
- Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary. - Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment and product by personnel and environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment and product by personnel and environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Equipment not clean 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is clean. - Equipment not clean 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is clean. - Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component. - Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component. - Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. - Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. - Master Production and Control Records 21 CFR 212.50(b)
You did not have master production and control records that document all steps in the PET drug production process. - Master Production and Control Records 21 CFR 212.50(b)
You did not have master production and control records that document all steps in the PET drug production process. - Testing Procedures- Conformance to Standards 21 CFR 212.60(b)
Each laboratory did not have testing procedures which are designed to ensure that components, in-process materials and PET drug products conform to appropriate standards including established standards of identity, strength, quality and purity. - Testing Procedures- Conformance to Standards 21 CFR 212.60(b)
Each laboratory did not have testing procedures which are designed to ensure that components, in-process materials and PET drug products conform to appropriate standards including established standards of identity, strength, quality and purity. - Lab written procedures 21 CFR 212.60(f)
Laboratory written procedures are not established and followed to ensure that the lab equipment is routinely calibrated, inspected, checked and maintained. - Lab written procedures 21 CFR 212.60(f)
Laboratory written procedures are not established and followed to ensure that the lab equipment is routinely calibrated, inspected, checked and maintained. - Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences. - Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
Registered with FDA for: manufacture.