Sunstar Inc.
⚠️ Moderate Risk
FEI: 1000114724 • Takatsuki, Osaka • JAPAN
FEI Number
1000114724
Location
Takatsuki, Osaka
Country
JAPANAddress
Sansuta (kabu), , Takatsuki, Osaka, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2014 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Chicago District Office (CHI-DO) | |
| 3/19/2008 | 25MYY01CARROT, JUICE OR DRINK | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 3/19/2008 | 25JYY12SWEET POTATO (ROOT & TUBER VEGETABLE) | Chicago District Office (CHI-DO) | |
| 1/14/2002 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/14/2002 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sunstar Inc.'s FDA import refusal history?
Sunstar Inc. (FEI: 1000114724) has 5 FDA import refusal record(s) in our database, spanning from 1/14/2002 to 6/23/2014.
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. Sunstar Inc.'s FEI number is 1000114724.
What types of violations has Sunstar Inc. received?
Sunstar Inc. 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 Sunstar Inc. come from?
All FDA import refusal data for Sunstar 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.