Company
FranceSPS MEDICAL, Coulommiers, France – FDA Inspections
Inspection records and compliance data for SPS MEDICAL in Coulommiers. 3 FDA inspections on record, 1 Form 483, last inspected May 30, 2024.
Company Profile
This profile covers SPS MEDICAL based in Coulommiers, France.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 6, 2014. Last inspected May 30, 2024.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Maintenance schedule, Lack of or inadequate schedule1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 30, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1241390 |
| January 18, 2018 | Not classified | Medical Devices & Rad Health | 1041592 |
| March 6, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 873445 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SPS MEDICAL
FEI Number
3006442872
Address
5 Rue De Montigny, Coulommiers, France
Country
France
ID: e6b2a0ba-228a-4890-9ec2-4456c08540e7