Frontida BioPharm Inc
⚠️ Moderate Risk
FEI: 2523348 • Philadelphia, PA • UNITED STATES
FEI Number
2523348
Location
Philadelphia, PA
Country
UNITED STATESAddress
1100 Orthodox St, , Philadelphia, PA, 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 |
|---|---|---|---|
| 12/12/2011 | 66FCA05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/21/2009 | 60SDA23METOCLOPRAMIDE (ANTACID) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 66MDA60THIORIDAZINE (TRANQUILIZER) | 179AGR RX | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Frontida BioPharm Inc's FDA import refusal history?
Frontida BioPharm Inc (FEI: 2523348) has 3 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 12/12/2011.
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. Frontida BioPharm Inc's FEI number is 2523348.
What types of violations has Frontida BioPharm Inc received?
Frontida BioPharm 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 Frontida BioPharm Inc come from?
All FDA import refusal data for Frontida BioPharm 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.