Company
United KingdomHelica Instruments, Ltd., Edinburgh, United Kingdom – FDA Inspections
Inspection records and compliance data for Helica Instruments, Ltd. in Edinburgh. 1 FDA inspection on record (1 OAI), last inspected November 11, 2015.
Company Profile
This profile covers Helica Instruments, Ltd. based in Edinburgh, United Kingdom.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected November 11, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - Lack of or inadequate procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 11, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 949799 |
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
Helica Instruments, Ltd.
FEI Number
3003824921
Address
Longstone, 102 Kingsknowe Road North, Edinburgh, United Kingdom
Country
United Kingdom
ID: 2885d9fb-14de-43c8-b757-c678e0a6b04f