FORMULATOR SAMPLE SHOP
⚠️ Moderate Risk
FEI: 3016809330 • Lincolnton, NC • UNITED STATES
FEI Number
3016809330
Location
Lincolnton, NC
Country
UNITED STATESAddress
202 Lithia Inn Rd, , Lincolnton, 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2020 | 54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 8/21/2020 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FORMULATOR SAMPLE SHOP's FDA import refusal history?
FORMULATOR SAMPLE SHOP (FEI: 3016809330) has 3 FDA import refusal record(s) in our database, spanning from 8/17/2020 to 11/12/2020.
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. FORMULATOR SAMPLE SHOP's FEI number is 3016809330.
What types of violations has FORMULATOR SAMPLE SHOP received?
FORMULATOR SAMPLE SHOP has been cited for 2 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 FORMULATOR SAMPLE SHOP come from?
All FDA import refusal data for FORMULATOR SAMPLE SHOP 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.