GMP Pharmaceuticals Ltd
⚠️ Moderate Risk
FEI: 3011150972 • Auckland, Auckland • NEW ZEALAND
FEI Number
3011150972
Location
Auckland, Auckland
Country
NEW ZEALANDAddress
12 Averton Place, East Tamaki, Auckland, Auckland, New Zealand
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
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
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 |
|---|---|---|---|
| 4/30/2014 | 54IBR99FIBER, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/30/2014 | 54IBR99FIBER, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/30/2014 | 54IBR99FIBER, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/30/2014 | 54IBR99FIBER, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is GMP Pharmaceuticals Ltd's FDA import refusal history?
GMP Pharmaceuticals Ltd (FEI: 3011150972) has 4 FDA import refusal record(s) in our database, spanning from 4/30/2014 to 4/30/2014.
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. GMP Pharmaceuticals Ltd's FEI number is 3011150972.
What types of violations has GMP Pharmaceuticals Ltd received?
GMP Pharmaceuticals Ltd 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 GMP Pharmaceuticals Ltd come from?
All FDA import refusal data for GMP Pharmaceuticals Ltd 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.