FDA Inspection
3D Imaging Drug Design and Development3D Imaging Drug Design and Development – FDA Inspection, Jun 13, 2025
Record Details
This FDA Inspection record concerns 3D Imaging Drug Design and Development, with an inspection on June 13, 2025, issued by the Dallas District Office, covering human drugs.
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ID · 110c05b6-92ad-4ba6-a7b3-089d7293b2a5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1272748
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.40(b)Written specifications - components
- 21 CFR 212.40(b)Written specifications - containers and closures
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.60(c)Analytical methods
- 21 CFR 212.60(e)Equipment
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Other FDA inspections of 3D Imaging Drug Design and Development
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 18, 2019 | VAI | Dallas District Office | Generic Drug Evaluation |
| April 20, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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