Company
IsraelDexcel Pharma Ltd., Or Akiva, Israel – FDA Inspections
Inspection records and compliance data for Dexcel Pharma Ltd. in Or Akiva. 4 FDA inspections on record, 2 Form 483s, last inspected December 14, 2022.
Company Profile
This profile covers Dexcel Pharma Ltd. based in Or Akiva, Israel.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 5, 2013. Last inspected December 14, 2022.
Most cited issue areas
- Computer control of master formula records1 inspection
- Control procedures to monitor and validate performance1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1195631 |
| July 24, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1097285 |
| February 16, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1007877 |
| June 5, 2013 | NAI | Human Drugs · Drug Quality Assurance | 836838 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dexcel Pharma Ltd.
FEI Number
3002806801
Address
Southern Industrial Zone, 1, Dexcel, Or Akiva, Israel
Country
Israel
ID: 4ec8aec2-8e4a-4886-8b52-f6d83c19e0c8