Biocor
⚠️ Moderate Risk
FEI: 3003630480 • Bnei Brak • ISRAEL
FEI Number
3003630480
Location
Bnei Brak
Country
ISRAELAddress
7 Hahashmonaim St, , Bnei Brak, , Israel
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/25/2008 | 64XAU99KERATOLYTIC N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/25/2008 | 64XAJ99KERATOLYTIC N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/25/2008 | 62SAJ99ANTI-SEBORRHEIC N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Biocor's FDA import refusal history?
Biocor (FEI: 3003630480) has 3 FDA import refusal record(s) in our database, spanning from 2/25/2008 to 2/25/2008.
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. Biocor's FEI number is 3003630480.
What types of violations has Biocor received?
Biocor 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 Biocor come from?
All FDA import refusal data for Biocor 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.