FDA Inspection
3D Imaging Drug Design and Development3D Imaging Drug Design and Development – FDA Inspection, Jan 18, 2019
Record Details
This FDA Inspection record concerns 3D Imaging Drug Design and Development, with an inspection on January 18, 2019, issued by the Dallas District Office, covering human drugs.
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ID · fa006bb2-0ae3-48d4-a205-c84f0d757d0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076821
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.50(c)(4)Each major production step
- 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 |
|---|---|---|---|
| June 13, 2025 | OAI | Dallas District Office | Drug Quality Assurance |
| January 31, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 20, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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