International Vitamin
⚠️ Moderate Risk
FEI: 1047823 • Greenville, SC • UNITED STATES
FEI Number
1047823
Location
Greenville, SC
Country
UNITED STATESAddress
1050 Woodruff Rd, , Greenville, SC, 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.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
SUPPL GMP
The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2013 | 54HBH04FISH OIL (FATS AND LIPID SUBSTANCES) | 3560SUPPL GMP | New York District Office (NYK-DO) |
| 7/9/2012 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 2120UNSFDIETSP | Atlanta District Office (ATL-DO) |
| 4/7/2009 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | San Francisco District Office (SAN-DO) |
| 5/20/2004 | 54FBP99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 238UNSAFE ADD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is International Vitamin's FDA import refusal history?
International Vitamin (FEI: 1047823) has 4 FDA import refusal record(s) in our database, spanning from 5/20/2004 to 4/22/2013.
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. International Vitamin's FEI number is 1047823.
What types of violations has International Vitamin received?
International Vitamin has been cited for 4 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 International Vitamin come from?
All FDA import refusal data for International Vitamin 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.