FH Industrie
⚠️ Moderate Risk
FEI: 3003898228 • Quimper, Finistere • FRANCE
FEI
FEI Number
3003898228
📍
Location
Quimper, Finistere
🇫🇷
Country
FRANCE🏢
Address
Zone Industrielle De Kernevez, 6 Rue Nobel, Quimper, Finistere, France
Moderate Risk
FDA Import Risk Assessment
40.5
LowModerateHighCritical
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
45
Total Refusals
1
Unique Violations
1/8/2018
Latest Refusal
1/8/2018
Earliest Refusal
Score Breakdown
Violation Severity
30.0×40%
Refusal Volume
61.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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
34145×
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 |
|---|---|---|---|
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87LZOPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/8/2018 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FH Industrie's FDA import refusal history?
FH Industrie (FEI: 3003898228) has 45 FDA import refusal record(s) in our database, spanning from 1/8/2018 to 1/8/2018.
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. FH Industrie's FEI number is 3003898228.
What types of violations has FH Industrie received?
FH Industrie 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 FH Industrie come from?
All FDA import refusal data for FH Industrie 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.