Bergmann S.A.C.I.
⚠️ Moderate Risk
FEI: 3003176455 • Munro, Buenos Aires • ARGENTINA
FEI Number
3003176455
Location
Munro, Buenos Aires
Country
ARGENTINAAddress
Calle Dr Carlos Tejedor 3425, , Munro, Buenos Aires, Argentina
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2002 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EKBEXPLORER, OPERATIVE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EIXPROBE, PERIODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76ELCSCALER, ULTRASONIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EIBSYRINGE, IRRIGATING (DENTAL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EKTCURETTE, ENDODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76JEXPLIER, ORTHODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EAXMIRROR, MOUTH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EHZEVACUATOR, ORAL CAVITY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2002 | 76EKRPLUGGER, ROOT CANAL, ENDODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bergmann S.A.C.I.'s FDA import refusal history?
Bergmann S.A.C.I. (FEI: 3003176455) has 11 FDA import refusal record(s) in our database, spanning from 12/13/2002 to 12/13/2002.
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. Bergmann S.A.C.I.'s FEI number is 3003176455.
What types of violations has Bergmann S.A.C.I. received?
Bergmann S.A.C.I. 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 Bergmann S.A.C.I. come from?
All FDA import refusal data for Bergmann S.A.C.I. 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.