WR Group
⚠️ Moderate Risk
FEI: 3006278664 • Phoenix, AZ • UNITED STATES
FEI Number
3006278664
Location
Phoenix, AZ
Country
UNITED STATESAddress
2625 S 16th St Ste 150, , Phoenix, AZ, 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
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).
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2016 | 54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 3/10/2016 | 09EGH29MILK AND MILK PRODUCTS, ADDED SAFE AND SUITABLE MICROBIAL ORGANISMS (E.G. LACTOBACILLUS ACIDOPHILUS) | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 3/10/2016 | 64RAD21SOMATROPIN (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/10/2016 | 64RAL21SOMATROPIN (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/10/2016 | 64RAD21SOMATROPIN (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/10/2016 | 64RAL21SOMATROPIN (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/25/2015 | 54YME99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/11/2015 | 64RCX18HUMAN GROWTH HORMONE (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/23/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is WR Group's FDA import refusal history?
WR Group (FEI: 3006278664) has 9 FDA import refusal record(s) in our database, spanning from 1/23/2012 to 3/10/2016.
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. WR Group's FEI number is 3006278664.
What types of violations has WR Group received?
WR Group 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 WR Group come from?
All FDA import refusal data for WR Group 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.