BIRTH SUPPLIES CANADA INC.
⚠️ Moderate Risk
FEI: 3014752434 • Calgary, Alberta • CANADA
FEI Number
3014752434
Location
Calgary, Alberta
Country
CANADAAddress
648 Lake Bonavista Dr Se, , Calgary, Alberta, 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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2018 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/20/2018 | 80KZHINTRODUCER, SYRINGE NEEDLE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/20/2018 | 65FCY05WATER, FOR INJECTION, BACTERIOSTATIC, U.S.P. (PHARMACEUTIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BIRTH SUPPLIES CANADA INC.'s FDA import refusal history?
BIRTH SUPPLIES CANADA INC. (FEI: 3014752434) has 4 FDA import refusal record(s) in our database, spanning from 11/20/2018 to 1/28/2019.
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. BIRTH SUPPLIES CANADA INC.'s FEI number is 3014752434.
What types of violations has BIRTH SUPPLIES CANADA INC. received?
BIRTH SUPPLIES CANADA INC. 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 BIRTH SUPPLIES CANADA INC. come from?
All FDA import refusal data for BIRTH SUPPLIES CANADA 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.