FDA Inspection
Panexcell Clinical Lab PVT. LTD.Panexcell Clinical Lab PVT. LTD. – FDA Inspection, Jan 19, 2018
Record Details
This FDA Inspection record concerns Panexcell Clinical Lab PVT. LTD., with an inspection on January 19, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Melkamu Getie Kebtie (Issuing Officer)
- Susanne M. Richardson (Company Rep)
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ID · 423ce0e3-5bed-4a14-82f4-4094b20c329e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1037990
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 312.64(c)Final study report
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Other FDA inspections of Panexcell Clinical Lab PVT. LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2019 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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