Company
FrancePatheon France S.A.S., Bourgoin Jallieu Cedex, France – FDA Inspections
Inspection records and compliance data for Patheon France S.A.S. in Bourgoin Jallieu Cedex. 6 FDA inspections on record, 2 Form 483s, last inspected September 29, 2023.
Company Profile
This profile covers Patheon France S.A.S. based in Bourgoin Jallieu Cedex, France.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 6
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected March 28, 2014. Last inspected September 29, 2023.
Most cited issue areas
- No written record of investigation1 inspection
- Procedures for non-sterile drug products1 inspection
- SOPs not followed / documented1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 29, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1267774 |
| September 27, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1135560 |
| October 19, 2018 | VAI | Human Drugs · New Drug Evaluation | 1069170 |
| June 8, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1055111 |
| March 11, 2016 | VAI | Human Drugs · Drug Quality Assurance | 964412 |
| March 28, 2014 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 871761 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Patheon France S.A.S.
FEI Number
3004468553
Address
Patheon, 40 Boulevard De Champaret; Cs 11006, Bourgoin Jallieu Cedex, France
Country
France
ID: 094a2977-7468-4413-a434-d808d4e5b87c