Firson Co., Ltd.
⚠️ High Risk
FEI: 3010219111 • Cheonan, Chungcheongnam • SOUTH KOREA
FEI Number
3010219111
Location
Cheonan, Chungcheongnam
Country
SOUTH KOREAAddress
Seobuk, 47 Baekseokgongdan 1-Ro, Cheonan, Chungcheongnam, South Korea
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
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).
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2017 | 61WBO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 61WBO31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 61WBO31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 61WBO31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 61WBO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 60QBJ69PRAMOXINE HCL (ANESTHETIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/7/2017 | 60CAK48OXYMETAZOLINE HCL (ADRENERGIC) | 78STERILITY | Division of West Coast Imports (DWCI) |
| 6/7/2017 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 78STERILITY | Division of West Coast Imports (DWCI) |
| 6/7/2017 | 60CAK48OXYMETAZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 5/31/2017 | 65FDK06WATER, PURIFIED (EYEWASH) | 78STERILITY | Division of Southeast Imports (DSEI) |
| 5/31/2017 | 56FBO14BACITRACIN, N.E.C. (PEPTIDES) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Firson Co., Ltd.'s FDA import refusal history?
Firson Co., Ltd. (FEI: 3010219111) has 11 FDA import refusal record(s) in our database, spanning from 5/31/2017 to 6/27/2017.
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. Firson Co., Ltd.'s FEI number is 3010219111.
What types of violations has Firson Co., Ltd. received?
Firson Co., Ltd. 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 Firson Co., Ltd. come from?
All FDA import refusal data for Firson Co., Ltd. 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.