Company
RomaniaSWISSCAPS Romania SRL, Cornu, Romania – FDA Inspections
Inspection records and compliance data for SWISSCAPS Romania SRL in Cornu. 5 FDA inspections on record, last inspected October 11, 2024.
Company Profile
This profile covers SWISSCAPS Romania SRL based in Cornu, Romania.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 19, 2016. Last inspected October 11, 2024.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Comparison of Test Results to Specifications1 inspection
- Procedure Deviations Recorded and Justified1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 11, 2024 | Not classified | Human Drugs | 1264152 |
| August 27, 2024 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 1248518 |
| August 21, 2019 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1102412 |
| May 11, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1124208 |
| February 19, 2016 | VAI | Human Drugs · Drug Quality Assurance | 961288 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SWISSCAPS Romania SRL
FEI Number
2000030299
Address
Carol I Street # 20, Cornu, Romania
Country
Romania
ID: 16482726-eaba-4a39-bbc5-b0861409684f