The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
⚠️ Moderate Risk
FEI: 1818658 • La Vergne, TN • UNITED STATES
FEI Number
1818658
Location
La Vergne, TN
Country
UNITED STATESAddress
341 Mason Rd, , La Vergne, TN, 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
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 |
|---|---|---|---|
| 3/22/2023 | 60CDV48OXYMETAZOLINE HCL (ADRENERGIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 60CDK10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 60SDA04ALUMINUM HYDROXIDE (ANTACID) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 60SDK15MAGNESIUM PHOSPHATE (ANTACID) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 61EDA08LORATADINE (ANTI-ASTHMATIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 64LDO37HYDROCORTISONE (GLUCOCORTICOID) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 56JDH20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 60LDK01ACETAMINOPHEN (ANALGESIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 9/3/2021 | 62FCL34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 60SDY22FAMOTIDINE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2012 | 60CCA57PSEUDOEPHEDRINE (ADRENERGIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 61WCO18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/1/2007 | 62GAP99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories's FDA import refusal history?
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories (FEI: 1818658) has 13 FDA import refusal record(s) in our database, spanning from 2/1/2007 to 3/22/2023.
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. The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories's FEI number is 1818658.
What types of violations has The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories received?
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories come from?
All FDA import refusal data for The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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.