Tender Corporation
⚠️ Moderate Risk
FEI: 1250045 • Littleton, NH • UNITED STATES
FEI Number
1250045
Location
Littleton, NH
Country
UNITED STATESAddress
944 Industrial Park Rd, , Littleton, NH, 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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2025 | 65RBK18SODIUM BICARBONATE (REPLENISHER) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/17/2023 | 65RAY18SODIUM BICARBONATE (REPLENISHER) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/30/2015 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | New York District Office (NYK-DO) | |
| 1/5/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/5/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Tender Corporation's FDA import refusal history?
Tender Corporation (FEI: 1250045) has 5 FDA import refusal record(s) in our database, spanning from 1/5/2012 to 10/17/2025.
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. Tender Corporation's FEI number is 1250045.
What types of violations has Tender Corporation received?
Tender Corporation has been cited for 3 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 Tender Corporation come from?
All FDA import refusal data for Tender Corporation 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.