Company
United KingdomRemel Europe Ltd., Dartford, United Kingdom – FDA Inspections
Inspection records and compliance data for Remel Europe Ltd. in Dartford. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 04, 2019.
Company Profile
This profile covers Remel Europe Ltd. based in Dartford, United Kingdom.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 9, 2009. Last inspected April 4, 2019.
Most cited issue areas
- Lack of or inadequate In-process acceptance procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Report of risk to health1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 4, 2019 | Not classified | Medical Devices & Rad Health | 1116790 |
| February 11, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 961738 |
| May 31, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 840261 |
| April 9, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 580616 |
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
Remel Europe Ltd.
FEI Number
3003750284
Address
Clipper Boulevard West, Ken, Dartford, United Kingdom
Country
United Kingdom
ID: c8f6163c-c8ee-4b78-921f-33b58016e464