Bd Advanced Bioprocessing Ca
⚠️ Moderate Risk
FEI: 3009076932 • Mississauga, Ontario • CANADA
FEI Number
3009076932
Location
Mississauga, Ontario
Country
CANADAAddress
100-2100 Derry Rd W, , Mississauga, Ontario, 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/30/2018 | 75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING) | Division of Southeast Imports (DSEI) | |
| 12/30/2015 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/10/2015 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/17/2015 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | Division of Southeast Imports (DSEI) | |
| 11/17/2015 | 82NZBQUALITY CONTROL MATERIAL, GENETICS, DNA | Division of Southeast Imports (DSEI) | |
| 11/13/2015 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | New Orleans District Office (NOL-DO) | |
| 11/12/2015 | 81MVUREAGENTS, SPECIFIC, ANALYTE | Division of Southeast Imports (DSEI) | |
| 11/12/2015 | 82NZBQUALITY CONTROL MATERIAL, GENETICS, DNA | New Orleans District Office (NOL-DO) | |
| 11/12/2015 | 82NZBQUALITY CONTROL MATERIAL, GENETICS, DNA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bd Advanced Bioprocessing Ca's FDA import refusal history?
Bd Advanced Bioprocessing Ca (FEI: 3009076932) has 9 FDA import refusal record(s) in our database, spanning from 11/12/2015 to 3/30/2018.
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. Bd Advanced Bioprocessing Ca's FEI number is 3009076932.
What types of violations has Bd Advanced Bioprocessing Ca received?
Bd Advanced Bioprocessing Ca 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 Bd Advanced Bioprocessing Ca come from?
All FDA import refusal data for Bd Advanced Bioprocessing Ca 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.