Mana Products, Inc.
⚠️ Moderate Risk
FEI: 2430738 • Long Island City, NY • UNITED STATES
FEI Number
2430738
Location
Long Island City, NY
Country
UNITED STATESAddress
3202 Queens Blvd, , Long Island City, NY, United States
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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 10/13/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 9/15/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 10/18/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 8/26/2009 | 53GY03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 8/26/2009 | 53GY03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/27/2009 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | New York District Office (NYK-DO) | |
| 11/16/2004 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mana Products, Inc.'s FDA import refusal history?
Mana Products, Inc. (FEI: 2430738) has 8 FDA import refusal record(s) in our database, spanning from 11/16/2004 to 10/13/2011.
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. Mana Products, Inc.'s FEI number is 2430738.
What types of violations has Mana Products, Inc. received?
Mana Products, Inc. has been cited for 4 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 Mana Products, Inc. come from?
All FDA import refusal data for Mana Products, Inc. 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.