GLOWHITE LTD
⚠️ Moderate Risk
FEI: 3009226578 • Milan • ITALY
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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active 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 |
|---|---|---|---|
| 12/9/2011 | 62GDJ99ANTI-INFLAMMATORY N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 53GH99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GLOWHITE LTD's FDA import refusal history?
GLOWHITE LTD (FEI: 3009226578) has 4 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 12/9/2011.
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. GLOWHITE LTD's FEI number is 3009226578.
What types of violations has GLOWHITE LTD received?
GLOWHITE LTD 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 GLOWHITE LTD come from?
All FDA import refusal data for GLOWHITE 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.