FDA Inspection
3D Imaging Drug Design and Development3D Imaging Drug Design and Development – FDA Inspection, Apr 20, 2017
Record Details
This FDA Inspection record concerns 3D Imaging Drug Design and Development, with an inspection on April 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Anh Lac (Issuing Officer)
- Shawn E. Larson (FDA Associated Person)
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ID · 64a48028-799f-499d-8317-f10bb4b44bfe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1009371
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 212.60(b)Testing Procedures- Conformance to Standards
- 21 CFR 212.60(f)Lab written procedures
- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.50(b)Master Production and Control Records
- 21 CFR 212.30(b)Equipment not clean
- 21 CFR 212.40(c)Use of reliable suppliers
- 21 CFR 212.30(a)Prevention of contamination
- 21 CFR 212.50Adequate controls (general)
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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 |
| January 18, 2019 | VAI | Dallas District Office | Generic Drug Evaluation |
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