Company
NetherlandsPatheon Softgels B.V., Tilburg, Netherlands – FDA Inspections
Inspection records and compliance data for Patheon Softgels B.V. in Tilburg. 4 FDA inspections on record, 1 Form 483, last inspected May 17, 2023.
Company Profile
This profile covers Patheon Softgels B.V. based in Tilburg, Netherlands.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected March 14, 2012. Last inspected May 17, 2023.
Most cited issue areas
- Computer control of master formula records1 inspection
- Investigations of discrepancies, failures1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 17, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1261181 |
| November 30, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1073073 |
| June 20, 2014 | VAI | Human Drugs · Drug Quality Assurance | 885869 |
| March 14, 2012 | VAI | Human Drugs · Drug Quality Assurance | 774336 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Patheon Softgels B.V.
FEI Number
1000384811
Address
De Posthoornstraat 7, Tilburg, Netherlands
Country
Netherlands
ID: 4bdd4c24-7239-474e-8d51-9b27b25347e1