Company
IsraelDexcel Pharma Technologies - Yokneam Factory, Yokne'Am Ilit, Israel – FDA Inspections
Inspection records and compliance data for Dexcel Pharma Technologies - Yokneam Factory in Yokne'Am Ilit. 3 FDA inspections on record, 1 Form 483, last inspected July 17, 2019.
Company Profile
This profile covers Dexcel Pharma Technologies - Yokneam Factory based in Yokne'Am Ilit, Israel.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 29, 2013. Last inspected July 17, 2019.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Calibration/Inspection/Checking not done1 inspection
- Control procedures to monitor and validate performance1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 17, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1096505 |
| February 25, 2016 | NAI | Human Drugs · Drug Quality Assurance | 964374 |
| May 29, 2013 | NAI | Human Drugs · Drug Quality Assurance | 836503 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Dexcel Pharma Technologies - Yokneam Factory
FEI Number
3008404887
Address
10, Ha-Kidma, Yokne'Am Ilit, Israel
Country
Israel
ID: c38b78b2-9227-419f-bc8f-e5e0faf75460