Novo Nordisk Pharmaceutical Industries LP
⚠️ High Risk
FEI: 1000158576 • Clayton, NC • UNITED STATES
FEI Number
1000158576
Location
Clayton, NC
Country
UNITED STATESAddress
3612 Powhatan Rd, , Clayton, NC, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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 |
|---|---|---|---|
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP07INSULIN DEGLUDEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 8/22/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 61PDY41INSULIN SUSP ISOPHANE/INSULIN BIOSYN HUM (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2024 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2024 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Novo Nordisk Pharmaceutical Industries LP's FDA import refusal history?
Novo Nordisk Pharmaceutical Industries LP (FEI: 1000158576) has 20 FDA import refusal record(s) in our database, spanning from 1/11/2024 to 11/4/2025.
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. Novo Nordisk Pharmaceutical Industries LP's FEI number is 1000158576.
What types of violations has Novo Nordisk Pharmaceutical Industries LP received?
Novo Nordisk Pharmaceutical Industries LP has been cited for 2 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 Novo Nordisk Pharmaceutical Industries LP come from?
All FDA import refusal data for Novo Nordisk Pharmaceutical Industries LP 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.