Aesculap-Chifa SP. Z.O.O.
⚠️ Moderate Risk
FEI: 3002315844 • Nowy Tomysl, Wielkopolskie • POLAND
FEI Number
3002315844
Location
Nowy Tomysl, Wielkopolskie
Country
POLANDAddress
Ul. Tysiaclecia 14, , Nowy Tomysl, Wielkopolskie, Poland
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2021 | 85KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/23/2021 | 85HHMSOUND, UTERINE | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/23/2021 | 79HTRRASP | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/23/2021 | 79EPYSPECULUM, ENT | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/23/2021 | 79HTDFORCEPS | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/23/2010 | 76DZNMATRIX, DENTAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Aesculap-Chifa SP. Z.O.O.'s FDA import refusal history?
Aesculap-Chifa SP. Z.O.O. (FEI: 3002315844) has 6 FDA import refusal record(s) in our database, spanning from 9/23/2010 to 6/23/2021.
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. Aesculap-Chifa SP. Z.O.O.'s FEI number is 3002315844.
What types of violations has Aesculap-Chifa SP. Z.O.O. received?
Aesculap-Chifa SP. Z.O.O. has been cited for 2 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 Aesculap-Chifa SP. Z.O.O. come from?
All FDA import refusal data for Aesculap-Chifa SP. Z.O.O. 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.