Company
FranceLaboratoire Unither, Coutances, France – FDA Inspections
Inspection records and compliance data for Laboratoire Unither in Coutances. 5 FDA inspections on record, 1 Form 483, last inspected October 22, 2021.
Company Profile
This profile covers Laboratoire Unither based in Coutances, France.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 16, 2011. Last inspected October 22, 2021.
Most cited issue areas
- Component addition checked by 2nd person1 inspection
- Identity Testing of Each Component1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 22, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1198468 |
| June 21, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1057672 |
| September 15, 2015 | VAI | Human Drugs · Drug Quality Assurance | 943780 |
| September 19, 2013 | VAI | Human Drugs · Drug Quality Assurance | 853044 |
| May 16, 2011 | VAI | Human Drugs · Drug Quality Assurance | 729962 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Laboratoire Unither
FEI Number
3006974616
Address
Zone Industrielle De La Guerie, 1 Rue De L Arquerie, Coutances, France
Country
France
ID: dde522e5-692a-43fc-9a7d-13913971abd3