Bachem AG
⚠️ Moderate Risk
FEI: 1000153019 • Bubendorf, Basle-Country • SWITZERLAND
FEI Number
1000153019
Location
Bubendorf, Basle-Country
Country
SWITZERLANDAddress
Haupt Strasse 144, , Bubendorf, Basle-Country, Switzerland
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
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
VET LEGEND
The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2015 | 62TCY04OCTREOTIDE ACETATE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/23/2014 | 64MIY02GONADORELIN ACETATE (GONAD-STIMULATING PRINCIPLE) | Division of Southeast Imports (DSEI) | |
| 4/24/2014 | 64MRA02GONADORELIN ACETATE (GONAD-STIMULATING PRINCIPLE) | Los Angeles District Office (LOS-DO) | |
| 4/2/2014 | 57VL99IN-VITRO DIAG PRODUCTS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/22/2013 | 62ZCA04TRIPTORELIN PAMOATE (ANTI-NEOPLASTIC - PART II) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/11/2013 | 61XCR01ANTAZOLINE PHOSPHATE (ANTI-HISTAMINIC) | New Orleans District Office (NOL-DO) | |
| 6/8/2012 | 64MCZ04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | New Orleans District Office (NOL-DO) | |
| 12/16/2008 | 64RIS99HORMONE N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/16/2008 | 62ZIS04TRIPTORELIN PAMOATE (ANTI-NEOPLASTIC - PART II) | Los Angeles District Office (LOS-DO) | |
| 6/2/2005 | 64RCY99HORMONE N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/19/2003 | 64RIY99HORMONE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2003 | 64MIY02GONADORELIN ACETATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2003 | 64RCY99HORMONE N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Bachem AG's FDA import refusal history?
Bachem AG (FEI: 1000153019) has 13 FDA import refusal record(s) in our database, spanning from 9/22/2003 to 2/24/2015.
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. Bachem AG's FEI number is 1000153019.
What types of violations has Bachem AG received?
Bachem AG has been cited for 4 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 Bachem AG come from?
All FDA import refusal data for Bachem AG 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.