Company
BelgiumALCON-COUVREUR N.V., Puurs-Sint-Amands, Belgium – FDA Inspections
Inspection records and compliance data for ALCON-COUVREUR N.V. in Puurs-Sint-Amands. 6 FDA inspections on record, 1 Form 483, last inspected March 05, 2025.
Company Profile
This profile covers ALCON-COUVREUR N.V. based in Puurs-Sint-Amands, Belgium.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 29, 2010. Last inspected March 5, 2025.
Most cited issue areas
- Complete test data included in records1 inspection
- Investigations of discrepancies, failures1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 5, 2025 | Not classified | Human Drugs | 1305248 |
| April 29, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1152317 |
| November 9, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1126883 |
| November 15, 2016 | VAI | Human Drugs · Drug Quality Assurance | 997972 |
| March 26, 2014 | NAI | Human Drugs · Drug Quality Assurance | 874952 |
| January 29, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645897 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
ALCON-COUVREUR N.V.
FEI Number
3002037047
Address
Rijksweg 14, Puurs-Sint-Amands, Belgium
Country
Belgium
ID: ae693345-797d-4e1c-8c0c-64fe6f82ec0b