Company
FranceApelem, Gallargues-Le-Montueux, France – FDA Inspections
Inspection records and compliance data for Apelem in Gallargues-Le-Montueux. 3 FDA inspections on record, 1 Form 483, last inspected December 08, 2022.
Company Profile
This profile covers Apelem based in Gallargues-Le-Montueux, France.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 26, 2017. Last inspected December 8, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- Installer records1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1194056 |
| January 25, 2019 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1082641 |
| January 26, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1002222 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Apelem
FEI Number
3000255482
Address
9 Avenue Du Canal Philippe Lamour, Gallargues-Le-Montueux, France
Country
France
ID: 64c64f08-6d00-4737-9e3b-6261487beb68