Biotech Inc
⚠️ Moderate Risk
FEI: 3003836370 • Markham, ON • CANADA
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2008 | 78MSYSTRIP, TEST, REAGENT, RESIDUALS FOR DIALYSATE, DISINFECTANT | New York District Office (NYK-DO) | |
| 1/28/2008 | 78MSYSTRIP, TEST, REAGENT, RESIDUALS FOR DIALYSATE, DISINFECTANT | New York District Office (NYK-DO) | |
| 1/28/2008 | 78MSYSTRIP, TEST, REAGENT, RESIDUALS FOR DIALYSATE, DISINFECTANT | New York District Office (NYK-DO) | |
| 1/28/2008 | 78MSYSTRIP, TEST, REAGENT, RESIDUALS FOR DIALYSATE, DISINFECTANT | New York District Office (NYK-DO) | |
| 1/28/2008 | 80KPDSTRIP, TEMPERATURE, FORHEAD, LIQUID CRYSTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/14/2007 | 81LJXTEST, URINE LEUKOCYTE | 336INCONSPICU | New York District Office (NYK-DO) |
| 5/14/2007 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 336INCONSPICU | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Biotech Inc's FDA import refusal history?
Biotech Inc (FEI: 3003836370) has 7 FDA import refusal record(s) in our database, spanning from 5/14/2007 to 1/28/2008.
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. Biotech Inc's FEI number is 3003836370.
What types of violations has Biotech Inc received?
Biotech Inc has been cited for 3 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 Biotech Inc come from?
All FDA import refusal data for Biotech Inc 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.