Company
FrancePerouse Medical, Irigny, France – FDA Inspections
Inspection records and compliance data for Perouse Medical in Irigny. 2 FDA inspections on record (1 OAI), last inspected December 11, 2014.
Company Profile
This profile covers Perouse Medical based in Irigny, France.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected November 21, 2013. Last inspected December 11, 2014.
Most cited issue areas
- Design validation - documentation1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - output does not meet input requirement1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 906580 |
| November 21, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 857492 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Perouse Medical
FEI Number
3004160911
Address
135 Route Neuve, Irigny, France
Country
France
ID: 8870cd7d-443f-48fa-b69e-14ed26ca8a44