FDA Inspection
Lewis, Karl D. MDLewis, Karl D. MD – FDA Inspection, Aug 7, 2023
Record Details
This FDA Inspection record concerns Lewis, Karl D. MD, with an inspection on August 7, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 0f4933f4-26cd-42f2-9b48-50b98f225f77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215417
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Copy of consent form not provided
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Other FDA inspections of Lewis, Karl D. MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Lewis, Karl D. MD
- FDA Inspection 913450 - 2015-02-20
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