Xlear Inc.
⚠️ Moderate Risk
FEI: 3010166224 • American Fork, UT • UNITED STATES
FEI Number
3010166224
Location
American Fork, UT
Country
UNITED STATESAddress
723 S Auto Mall Dr, , American Fork, UT, 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
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2008 | 33UGT99CHEWING GUM, N.E.C. (WITHOUT CHOCOLATE) | 321LACKS N/C | New York District Office (NYK-DO) |
| 5/16/2008 | 33UGT99CHEWING GUM, N.E.C. (WITHOUT CHOCOLATE) | 321LACKS N/C | New York District Office (NYK-DO) |
| 5/16/2008 | 33UGT99CHEWING GUM, N.E.C. (WITHOUT CHOCOLATE) | 321LACKS N/C | New York District Office (NYK-DO) |
| 5/16/2008 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/16/2008 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/11/2007 | 36AFH99SUGAR PRODUCTS, N.E.C. | 488HEALTH C | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Xlear Inc.'s FDA import refusal history?
Xlear Inc. (FEI: 3010166224) has 6 FDA import refusal record(s) in our database, spanning from 9/11/2007 to 5/16/2008.
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. Xlear Inc.'s FEI number is 3010166224.
What types of violations has Xlear Inc. received?
Xlear Inc. 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 Xlear Inc. come from?
All FDA import refusal data for Xlear 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.