Hi-Tech Pharmaceuticals Inc.
⚠️ Moderate Risk
FEI: 3001859902 • Norcross, GA • UNITED STATES
FEI Number
3001859902
Location
Norcross, GA
Country
UNITED STATESAddress
6015 Unity Dr Ste B, , Norcross, GA, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
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 |
|---|---|---|---|
| 6/30/2009 | 54FCB09EPHEDRA (HERBAL & BOTANICALS, NOT TEAS) | Florida District Office (FLA-DO) | |
| 6/30/2009 | 54FCB09EPHEDRA (HERBAL & BOTANICALS, NOT TEAS) | Florida District Office (FLA-DO) | |
| 6/30/2009 | 54FCB75COCCULUS | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 3/21/2008 | 60NCA03METHANDROSTENOLONE (ANDROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hi-Tech Pharmaceuticals Inc.'s FDA import refusal history?
Hi-Tech Pharmaceuticals Inc. (FEI: 3001859902) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2008 to 6/30/2009.
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. Hi-Tech Pharmaceuticals Inc.'s FEI number is 3001859902.
What types of violations has Hi-Tech Pharmaceuticals Inc. received?
Hi-Tech Pharmaceuticals Inc. 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 Hi-Tech Pharmaceuticals Inc. come from?
All FDA import refusal data for Hi-Tech Pharmaceuticals 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.