IBSA Institut Biochimique SA
⚠️ High Risk
FEI: 3002864272 • Pazzallo, Ticino • SWITZERLAND
FEI Number
3002864272
Location
Pazzallo, Ticino
Country
SWITZERLANDAddress
Via Pian Scairolo 49, , Pazzallo, Ticino, Switzerland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 4/30/2024 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 9/22/2023 | 64MDY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 58JDZ99GONAD-STIMULATING PRINCIPLE, NEC | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2022 | 64MCY10UROFOLLITROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 64MCY10UROFOLLITROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/29/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/2/2010 | 66JCH01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 2/9/2007 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/9/2007 | 62GCJ46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/9/2007 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2005 | 64MAZ05MENOTROPINS (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is IBSA Institut Biochimique SA's FDA import refusal history?
IBSA Institut Biochimique SA (FEI: 3002864272) has 11 FDA import refusal record(s) in our database, spanning from 11/18/2005 to 4/30/2024.
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. IBSA Institut Biochimique SA's FEI number is 3002864272.
What types of violations has IBSA Institut Biochimique SA received?
IBSA Institut Biochimique SA has been cited for 5 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 IBSA Institut Biochimique SA come from?
All FDA import refusal data for IBSA Institut Biochimique SA 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.