Company
HungarySanatmetal LTD., Eger, Hungary – FDA Inspections
Inspection records and compliance data for Sanatmetal LTD. in Eger. 3 FDA inspections on record (1 OAI), last inspected November 19, 2014.
Company Profile
This profile covers Sanatmetal LTD. based in Eger, Hungary.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 17, 2009. Last inspected November 19, 2014.
Most cited issue areas
- Acceptance criteria not identified1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 19, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 905850 |
| September 13, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 799552 |
| September 17, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 615769 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sanatmetal LTD.
FEI Number
3002962587
Address
Faiskola Utca 5, Eger, Hungary
Country
Hungary
ID: b171e4c6-34d3-48aa-b81c-2ce6d3245453