Company
United KingdomORTHO-CLINICAL DIAGNOSTICS, Bridgend, United Kingdom – FDA Inspections
Inspection records and compliance data for ORTHO-CLINICAL DIAGNOSTICS in Bridgend. 6 FDA inspections on record, last inspected February 01, 2018.
Company Profile
This profile covers ORTHO-CLINICAL DIAGNOSTICS based in Bridgend, United Kingdom.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 12, 2009. Last inspected February 1, 2018.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 1, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1047221 |
| September 21, 2017 | Not classified | Biologics | 1032236 |
| May 1, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 882853 |
| May 6, 2011 | NAI | Biologics, Medical Devices & Rad Health · Bioresearch Monitoring | 729764 |
| May 12, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 666443 |
| October 12, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 635447 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ORTHO-CLINICAL DIAGNOSTICS
FEI Number
3007111389
Address
Felindre Meadows, Bridgend, United Kingdom
Country
United Kingdom
ID: 4460c1fd-67df-4ea1-a4ff-ee8971579628