Acme United Corporation
⚠️ Moderate Risk
FEI: 1030186 • Rocky Mount, NC • UNITED STATES
FEI Number
1030186
Location
Rocky Mount, NC
Country
UNITED STATESAddress
2280 Tanner Rd, , Rocky Mount, NC, 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 |
|---|---|---|---|
| 11/16/2023 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 11/16/2023 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 11/16/2023 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 11/16/2023 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 12/6/2017 | 61TAA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/6/2017 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2017 | 60QBO40LIDOCAINE HCL (ANESTHETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2017 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2017 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2017 | 80FQMBANDAGE, ELASTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Acme United Corporation's FDA import refusal history?
Acme United Corporation (FEI: 1030186) has 10 FDA import refusal record(s) in our database, spanning from 12/6/2017 to 11/16/2023.
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. Acme United Corporation's FEI number is 1030186.
What types of violations has Acme United Corporation received?
Acme United 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 Acme United Corporation come from?
All FDA import refusal data for Acme United 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.