Company
United KingdomORTHO SOLUTIONS, LTD., Maldon, United Kingdom – FDA Inspections
Inspection records and compliance data for ORTHO SOLUTIONS, LTD. in Maldon. 2 FDA inspections on record, 1 Form 483, last inspected April 21, 2017.
Company Profile
This profile covers ORTHO SOLUTIONS, LTD. based in Maldon, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 10, 2014. Last inspected April 21, 2017.
Most cited issue areas
- DMR - not or inadequately maintained1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1019552 |
| April 10, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 883139 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ORTHO SOLUTIONS, LTD.
FEI Number
3008951116
Address
West Station Business Park, Spital Road, Maldon, United Kingdom
Country
United Kingdom
ID: 3f90c462-9475-4266-bf9f-da26abfb15a9