Gano Excel Industries
⚠️ Moderate Risk
FEI: 3009952934 • Jitra, Kedah • MALAYSIA
FEI Number
3009952934
Location
Jitra, Kedah
Country
MALAYSIAAddress
Lot 2774, Pekan Asun, Lebuhraya Bukit Kayu Hitam, Jitra, Kedah, Malaysia
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIETARYLBL
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(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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.
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).
NCONTACTS
The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2015 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 10/9/2014 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Cincinnati District Office (CIN-DO) | |
| 10/9/2014 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 4/10/2014 | 31ADE03COFFEE, INSTANT | San Francisco District Office (SAN-DO) | |
| 4/9/2014 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 475COSMETLBLG | Seattle District Office (SEA-DO) |
| 3/26/2014 | 31ADE03COFFEE, INSTANT | Seattle District Office (SEA-DO) | |
| 3/26/2014 | 31ADE03COFFEE, INSTANT | Seattle District Office (SEA-DO) | |
| 3/6/2014 | 31ADE03COFFEE, INSTANT | Seattle District Office (SEA-DO) | |
| 3/6/2014 | 31ADE03COFFEE, INSTANT | Seattle District Office (SEA-DO) | |
| 7/29/2013 | 54FYH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 218LIST INGRE | New Orleans District Office (NOL-DO) |
| 6/4/2013 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Gano Excel Industries's FDA import refusal history?
Gano Excel Industries (FEI: 3009952934) has 11 FDA import refusal record(s) in our database, spanning from 6/4/2013 to 5/4/2015.
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. Gano Excel Industries's FEI number is 3009952934.
What types of violations has Gano Excel Industries received?
Gano Excel Industries has been cited for 8 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 Gano Excel Industries come from?
All FDA import refusal data for Gano Excel Industries 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.