GALAXY INTERNATIONAL
⚠️ Moderate Risk
FEI: 3013191486 • Panvel, Maharashtra • INDIA
FEI Number
3013191486
Location
Panvel, Maharashtra
Country
INDIAAddress
Paras Complex, 73/74 Opp - Jay Malhar; Survey, Panvel, Maharashtra, India
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
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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).
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/30/2019 | 21TGT14TAMARIND, DRIED OR PASTE | 249FILTHY | Division of Northeast Imports (DNEI) |
| 1/30/2017 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 10/20/2016 | 28AGT99WHOLE SPICE, N.E.C. | 9SALMONELLA | Chicago District Office (CHI-DO) |
| 10/20/2016 | 28AGT99WHOLE SPICE, N.E.C. | 9SALMONELLA | Chicago District Office (CHI-DO) |
| 6/19/2013 | 65RBZ18SODIUM BICARBONATE (REPLENISHER) | Division of Northeast Imports (DNEI) | |
| 6/19/2013 | 65SBO99RUBEFACIENT N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/19/2013 | 65SBO99RUBEFACIENT N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is GALAXY INTERNATIONAL's FDA import refusal history?
GALAXY INTERNATIONAL (FEI: 3013191486) has 7 FDA import refusal record(s) in our database, spanning from 6/19/2013 to 5/30/2019.
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. GALAXY INTERNATIONAL's FEI number is 3013191486.
What types of violations has GALAXY INTERNATIONAL received?
GALAXY INTERNATIONAL has been cited for 7 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 GALAXY INTERNATIONAL come from?
All FDA import refusal data for GALAXY INTERNATIONAL 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.