Lgi Labs
⚠️ Moderate Risk
FEI: 3007477705 • Aurora, ON • CANADA
FEI Number
3007477705
Location
Aurora, ON
Country
CANADAAddress
219 Old Yonge St, , Aurora, 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
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2011 | 57AH02BOTULISM ANTITOXIN | Detroit District Office (DET-DO) | |
| 4/15/2011 | 83KZICULTURE MEDIA, ENRICHED | 336INCONSPICU | Detroit District Office (DET-DO) |
| 4/15/2011 | 83KZICULTURE MEDIA, ENRICHED | 336INCONSPICU | Detroit District Office (DET-DO) |
| 4/15/2011 | 83KZICULTURE MEDIA, ENRICHED | 336INCONSPICU | Detroit District Office (DET-DO) |
| 4/15/2011 | 83KZICULTURE MEDIA, ENRICHED | 336INCONSPICU | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Lgi Labs's FDA import refusal history?
Lgi Labs (FEI: 3007477705) has 5 FDA import refusal record(s) in our database, spanning from 4/15/2011 to 10/14/2011.
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. Lgi Labs's FEI number is 3007477705.
What types of violations has Lgi Labs received?
Lgi Labs 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 Lgi Labs come from?
All FDA import refusal data for Lgi Labs 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.