FFDM TIVOLY
⚠️ Moderate Risk
FEI: 3003120222 • Bourges Cedex, Cher • FRANCE
FEI Number
3003120222
Location
Bourges Cedex, Cher
Country
FRANCEAddress
Ffdm Pneumat, 78 Avenue De La Prospective; Cs 30001, Bourges Cedex, Cher, France
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2012 | 76EJYPLIERS, OPERATIVE | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/5/2011 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/6/2010 | 76EJLBUR, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EJLBUR, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EJLBUR, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EJLBUR, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EJLBUR, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EJLBUR, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76LTGPASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKAFILE, MARGIN FINISHING, OPERATIVE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKAFILE, MARGIN FINISHING, OPERATIVE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKRPLUGGER, ROOT CANAL, ENDODONTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKAFILE, MARGIN FINISHING, OPERATIVE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKAFILE, MARGIN FINISHING, OPERATIVE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKPREAMER, PULP CANAL, ENDODONTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKPREAMER, PULP CANAL, ENDODONTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 76EKWBROACH, ENDODONTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/2/2009 | 76EJLBUR, DENTAL | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 1/14/2005 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/7/2001 | 76EJLBUR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 12/7/2001 | 76EJLBUR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 12/7/2001 | 76EJLBUR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 12/7/2001 | 76EAHCONE, RADIOGRAPHIC, LEAD-LINED | Los Angeles District Office (LOS-DO) | |
| 12/7/2001 | 76EJLBUR, DENTAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is FFDM TIVOLY's FDA import refusal history?
FFDM TIVOLY (FEI: 3003120222) has 26 FDA import refusal record(s) in our database, spanning from 12/7/2001 to 3/23/2012.
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. FFDM TIVOLY's FEI number is 3003120222.
What types of violations has FFDM TIVOLY received?
FFDM TIVOLY has been cited for 3 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 FFDM TIVOLY come from?
All FDA import refusal data for FFDM TIVOLY 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.