Company
United KingdomOsteotec Limited, Christchurch, United Kingdom – FDA Inspections
Inspection records and compliance data for Osteotec Limited in Christchurch. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected September 04, 2018.
Company Profile
This profile covers Osteotec Limited based in Christchurch, United Kingdom.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected September 4, 2018.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design validation - production units1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 4, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1064322 |
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
Osteotec Limited
FEI Number
3008395366
Address
Unit 9, Silver Business Park; Airfield Way, Christchurch, United Kingdom
Country
United Kingdom
ID: 9522ca5b-7846-4d44-b2c6-c7a144f071bc