TLC PHARMACEUTICAL STANDARDS LTD
⚠️ Moderate Risk
FEI: 3013612966 • Aurora, Ontario • CANADA
FEI Number
3013612966
Location
Aurora, Ontario
Country
CANADAAddress
Parkwaysouth, Unit 7 8; 305 Industrial Pky S, Aurora, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 10/12/2018 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/12/2018 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/12/2018 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TLC PHARMACEUTICAL STANDARDS LTD's FDA import refusal history?
TLC PHARMACEUTICAL STANDARDS LTD (FEI: 3013612966) has 3 FDA import refusal record(s) in our database, spanning from 10/12/2018 to 10/12/2018.
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. TLC PHARMACEUTICAL STANDARDS LTD's FEI number is 3013612966.
What types of violations has TLC PHARMACEUTICAL STANDARDS LTD received?
TLC PHARMACEUTICAL STANDARDS LTD 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 TLC PHARMACEUTICAL STANDARDS LTD come from?
All FDA import refusal data for TLC PHARMACEUTICAL STANDARDS LTD 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.