Celex Laboratories Inc.
⚠️ Moderate Risk
FEI: 3006525144 • Richmond, British Columbia • CANADA
FEI Number
3006525144
Location
Richmond, British Columbia
Country
CANADAAddress
115-21600 Westminster Hwy, , Richmond, British Columbia, 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
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2019 | 54FDE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3864NCONTACT | Division of Northern Border Imports (DNBI) |
| 9/13/2019 | 54FDE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3864NCONTACT | Division of Northern Border Imports (DNBI) |
| 9/13/2019 | 54FDE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3864NCONTACT | Division of Northern Border Imports (DNBI) |
| 9/13/2019 | 54FEE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3864NCONTACT | Division of Northern Border Imports (DNBI) |
| 9/13/2019 | 54FEE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3864NCONTACT | Division of Northern Border Imports (DNBI) |
| 9/13/2019 | 54GEE99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Celex Laboratories Inc.'s FDA import refusal history?
Celex Laboratories Inc. (FEI: 3006525144) has 6 FDA import refusal record(s) in our database, spanning from 9/13/2019 to 9/13/2019.
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. Celex Laboratories Inc.'s FEI number is 3006525144.
What types of violations has Celex Laboratories Inc. received?
Celex Laboratories Inc. has been cited for 2 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 Celex Laboratories Inc. come from?
All FDA import refusal data for Celex Laboratories 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.