Reglo Products Wholesle/distributing
⚠️ Moderate Risk
FEI: 3013498157 • Saint George'S • GRENADA
FEI Number
3013498157
Location
Saint George'S
Country
GRENADAAddress
Mt Morris, , Saint George'S, , Grenada
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
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/5/2017 | 31KFT99TEA, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/5/2017 | 31KFT99TEA, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/5/2017 | 31KFT99TEA, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/5/2017 | 31KFT99TEA, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/5/2017 | 31PFH99TEA SUBSTITUTES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/5/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Reglo Products Wholesle/distributing's FDA import refusal history?
Reglo Products Wholesle/distributing (FEI: 3013498157) has 6 FDA import refusal record(s) in our database, spanning from 7/5/2017 to 7/5/2017.
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. Reglo Products Wholesle/distributing's FEI number is 3013498157.
What types of violations has Reglo Products Wholesle/distributing received?
Reglo Products Wholesle/distributing has been cited for 6 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 Reglo Products Wholesle/distributing come from?
All FDA import refusal data for Reglo Products Wholesle/distributing 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.