POLA Co., Ltd.
⚠️ Moderate Risk
FEI: 3001761597 • Shinagawa, Tokyo • JAPAN
FEI Number
3001761597
Location
Shinagawa, Tokyo
Country
JAPANAddress
2 Chome 2-3, Nishigotanda, Shinagawa, Tokyo, Japan
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).
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.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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).
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2023 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 12/22/2014 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | Cincinnati District Office (CIN-DO) | |
| 12/22/2014 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | Cincinnati District Office (CIN-DO) | |
| 8/27/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Los Angeles District Office (LOS-DO) |
| 8/27/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/27/2009 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/26/2009 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/9/2004 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 2/26/2003 | 25SCH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 482NUTRIT LBL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is POLA Co., Ltd.'s FDA import refusal history?
POLA Co., Ltd. (FEI: 3001761597) has 9 FDA import refusal record(s) in our database, spanning from 2/26/2003 to 10/17/2023.
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. POLA Co., Ltd.'s FEI number is 3001761597.
What types of violations has POLA Co., Ltd. received?
POLA Co., 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 POLA Co., Ltd. come from?
All FDA import refusal data for POLA Co., 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.