Company
DenmarkAdvalight ApS, Ballerup, Denmark – FDA Inspections
Inspection records and compliance data for Advalight ApS in Ballerup. 3 FDA inspections on record, 1 Form 483, last inspected April 11, 2024.
Company Profile
This profile covers Advalight ApS based in Ballerup, Denmark.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 26, 2015. Last inspected April 11, 2024.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate process validation1 inspection
- Software validation for automated processes1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 11, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1235694 |
| April 19, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1049187 |
| November 26, 2015 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 950736 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Advalight ApS
FEI Number
3010683226
Address
Industriparken 22a, Ballerup, Denmark
Country
Denmark
ID: a67b50d1-6457-422c-ae66-d15e2aa1369b