Company
SwitzerlandSIE AG, Surgical Instrument Engineering, Port, Switzerland – FDA Inspections
Inspection records and compliance data for SIE AG, Surgical Instrument Engineering in Port. 1 FDA inspection on record (1 OAI), last inspected September 18, 2014.
Company Profile
This profile covers SIE AG, Surgical Instrument Engineering based in Port, Switzerland.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected September 18, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Failure to submit1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 899746 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
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Company Information
Name
SIE AG, Surgical Instrument Engineering
FEI Number
3005643720
Address
Allmendstrasse 11, Port, Switzerland
Country
Switzerland
ID: d71dd271-f325-4cda-ba2a-72594d6e17d0