Sagami Rubber Industries Co., Ltd.
⚠️ Moderate Risk
FEI: 3002808077 • Atsugi, Kanagawa • JAPAN
FEI Number
3002808077
Location
Atsugi, Kanagawa
Country
JAPANAddress
2-1, Moto-Machi, Atsugi, Kanagawa, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2022 | 85HISCONDOM | Division of Northern Border Imports (DNBI) | |
| 6/27/2019 | 85HISCONDOM | 3260NO ENGLISH | Division of West Coast Imports (DWCI) |
| 3/27/2017 | 85HISCONDOM | Division of Southeast Imports (DSEI) | |
| 3/9/2017 | 85HISCONDOM | Division of Southeast Imports (DSEI) | |
| 2/16/2017 | 85HISCONDOM | 3260NO ENGLISH | Division of Northern Border Imports (DNBI) |
| 2/16/2017 | 85HISCONDOM | 3260NO ENGLISH | Division of Northern Border Imports (DNBI) |
| 1/9/2017 | 85HISCONDOM | 3260NO ENGLISH | Cincinnati District Office (CIN-DO) |
| 7/20/2016 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 7/11/2016 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 7/7/2016 | 85HISCONDOM | Seattle District Office (SEA-DO) | |
| 3/27/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/2/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 8/20/2012 | 85HISCONDOM | 477HOLES | Baltimore District Office (BLT-DO) |
| 10/21/2010 | 85HISCONDOM | 477HOLES | Baltimore District Office (BLT-DO) |
| 12/11/2001 | 78GBTCATHETER, RECTAL | 508NO 510(K) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Sagami Rubber Industries Co., Ltd.'s FDA import refusal history?
Sagami Rubber Industries Co., Ltd. (FEI: 3002808077) has 15 FDA import refusal record(s) in our database, spanning from 12/11/2001 to 4/5/2022.
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. Sagami Rubber Industries Co., Ltd.'s FEI number is 3002808077.
What types of violations has Sagami Rubber Industries Co., Ltd. received?
Sagami Rubber Industries Co., Ltd. has been cited for 6 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 Sagami Rubber Industries Co., Ltd. come from?
All FDA import refusal data for Sagami Rubber Industries 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.