Company
FranceOpella Healthcare International SAS, Compiegne, France – FDA Inspections
Inspection records and compliance data for Opella Healthcare International SAS in Compiegne. 6 FDA inspections on record, 1 Form 483, last inspected January 10, 2025.
Company Profile
This profile covers Opella Healthcare International SAS based in Compiegne, France.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 21, 2011. Last inspected January 10, 2025.
Most cited issue areas
- Annual visual exams of drug products1 inspection
- Complaint Handling Procedure1 inspection
- Complete Test Data1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 10, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1268935 |
| October 31, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1123990 |
| June 23, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1015497 |
| September 18, 2015 | VAI | Human Drugs · Drug Quality Assurance | 946883 |
| September 19, 2013 | VAI | Human Drugs · Drug Quality Assurance | 853427 |
| October 21, 2011 | NAI | Human Drugs · Drug Quality Assurance | 754638 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Opella Healthcare International SAS
FEI Number
3003492806
Address
56 Route De Choisy, Compiegne, France
Country
France
ID: 53ed93ee-b631-49a0-bba2-a57194143394