HR Pharmaceuticals, Inc
⚠️ High Risk
FEI: 3008502431 • York, PA • UNITED STATES
FEI Number
3008502431
Location
York, PA
Country
UNITED STATESAddress
3630 Concord Rd, , York, PA, 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
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 80KMJLUBRICANT, PATIENT | Division of West Coast Imports (DWCI) | |
| 10/6/2023 | 80KMJLUBRICANT, PATIENT | 16DIRECTIONS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is HR Pharmaceuticals, Inc's FDA import refusal history?
HR Pharmaceuticals, Inc (FEI: 3008502431) has 7 FDA import refusal record(s) in our database, spanning from 10/6/2023 to 4/2/2024.
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. HR Pharmaceuticals, Inc's FEI number is 3008502431.
What types of violations has HR Pharmaceuticals, Inc received?
HR Pharmaceuticals, Inc 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 HR Pharmaceuticals, Inc come from?
All FDA import refusal data for HR 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.