Meena Exporters
⚠️ Moderate Risk
FEI: 3003715595 • Gujarat • INDIA
FEI Number
3003715595
Location
Gujarat
Country
INDIAAddress
Shakti Cinema Compoundode388210, , Gujarat, , 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
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.
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.
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 |
|---|---|---|---|
| 7/28/2005 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | New York District Office (NYK-DO) |
| 6/15/2005 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/15/2005 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/4/2004 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Meena Exporters's FDA import refusal history?
Meena Exporters (FEI: 3003715595) has 4 FDA import refusal record(s) in our database, spanning from 8/4/2004 to 7/28/2005.
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. Meena Exporters's FEI number is 3003715595.
What types of violations has Meena Exporters received?
Meena Exporters has been cited for 5 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 Meena Exporters come from?
All FDA import refusal data for Meena Exporters 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.