De France Productions Ltd.
✅ Low Risk
FEI: 3003074475 • Auckland • NEW ZEALAND
FEI Number
3003074475
Location
Auckland
Country
NEW ZEALANDAddress
Po Box 277 4143 Boston Road, , Auckland, , New Zealand
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2002 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is De France Productions Ltd.'s FDA import refusal history?
De France Productions Ltd. (FEI: 3003074475) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2002 to 6/13/2002.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. De France Productions Ltd.'s FEI number is 3003074475.
What types of violations has De France Productions Ltd. received?
De France Productions Ltd. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about De France Productions Ltd. come from?
All FDA import refusal data for De France Productions Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.