NOW Health Group Inc.
⚠️ Moderate Risk
FEI: 1482865 • Bloomingdale, IL • UNITED STATES
FEI Number
1482865
Location
Bloomingdale, IL
Country
UNITED STATESAddress
395 Glen Ellyn Rd, , Bloomingdale, IL, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NUTRIT LBL
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 fails to bear the required nutrition information.
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.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2017 | 54AFM16VITAMIN E (TOCOPHEROL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/5/2006 | 60SDY07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 179AGR RX | San Francisco District Office (SAN-DO) |
| 3/28/2005 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 11/22/2004 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 11/22/2004 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 9/20/2004 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 9/20/2004 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is NOW Health Group Inc.'s FDA import refusal history?
NOW Health Group Inc. (FEI: 1482865) has 7 FDA import refusal record(s) in our database, spanning from 9/20/2004 to 4/5/2017.
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. NOW Health Group Inc.'s FEI number is 1482865.
What types of violations has NOW Health Group Inc. received?
NOW Health Group Inc. has been cited for 5 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 NOW Health Group Inc. come from?
All FDA import refusal data for NOW Health Group 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.