Glanbia Performance Nutrition, Inc
⚠️ Moderate Risk
FEI: 1000114049 • Sunrise, FL • UNITED STATES
FEI Number
1000114049
Location
Sunrise, FL
Country
UNITED STATESAddress
403 Sawgrass Corporate Pkwy, , Sunrise, FL, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2017 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2017 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2017 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2017 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2017 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2017 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/23/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/23/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/23/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/23/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/27/2015 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 10/31/2011 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 10/31/2011 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 10/31/2011 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 292SUBSTITUTE | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 292SUBSTITUTE | New Orleans District Office (NOL-DO) |
| 10/29/2004 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 2120UNSFDIETSP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Glanbia Performance Nutrition, Inc's FDA import refusal history?
Glanbia Performance Nutrition, Inc (FEI: 1000114049) has 24 FDA import refusal record(s) in our database, spanning from 10/29/2004 to 3/31/2017.
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. Glanbia Performance Nutrition, Inc's FEI number is 1000114049.
What types of violations has Glanbia Performance Nutrition, Inc received?
Glanbia Performance Nutrition, Inc has been cited for 7 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 Glanbia Performance Nutrition, Inc come from?
All FDA import refusal data for Glanbia Performance Nutrition, 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.