Front Pharmaceutical PLC
⚠️ Moderate Risk
FEI: 3011575652 • Xuancheng, Anhui • CHINA
FEI Number
3011575652
Location
Xuancheng, Anhui
Country
CHINAAddress
No. 369 Baocheng Road, Technical Development Zone, Xuancheng, Anhui, China
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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/5/2023 | 61WBJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/3/2021 | 63HBJ15MINERAL OIL (CATHARTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/7/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Front Pharmaceutical PLC's FDA import refusal history?
Front Pharmaceutical PLC (FEI: 3011575652) has 3 FDA import refusal record(s) in our database, spanning from 12/7/2017 to 10/5/2023.
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. Front Pharmaceutical PLC's FEI number is 3011575652.
What types of violations has Front Pharmaceutical PLC received?
Front Pharmaceutical PLC 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 Front Pharmaceutical PLC come from?
All FDA import refusal data for Front Pharmaceutical PLC 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.