Fung Song Pharm Biotechnology Co., Ltd.
⚠️ High Risk
FEI: 3004960563 • Tainan, TW-TNN • TAIWAN
FEI Number
3004960563
Location
Tainan, TW-TNN
Country
TAIWANAddress
No. 60 Chengong St, Guantian Township, Tainan, TW-TNN, Taiwan
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
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).
UNSFDIETUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2006 | 54EBK12GINSENG (HERBAL & BOTANICAL TEAS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/7/2006 | 54EBK12GINSENG (HERBAL & BOTANICAL TEAS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 54EBK12GINSENG (HERBAL & BOTANICAL TEAS) | 2461UNSFDIETUS | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 54EBK12GINSENG (HERBAL & BOTANICAL TEAS) | 2461UNSFDIETUS | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 54EBK12GINSENG (HERBAL & BOTANICAL TEAS) | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 79KGXTAPE AND BANDAGE, ADHESIVE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Fung Song Pharm Biotechnology Co., Ltd.'s FDA import refusal history?
Fung Song Pharm Biotechnology Co., Ltd. (FEI: 3004960563) has 8 FDA import refusal record(s) in our database, spanning from 10/25/2005 to 6/7/2006.
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. Fung Song Pharm Biotechnology Co., Ltd.'s FEI number is 3004960563.
What types of violations has Fung Song Pharm Biotechnology Co., Ltd. received?
Fung Song Pharm Biotechnology Co., Ltd. has been cited for 4 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 Fung Song Pharm Biotechnology Co., Ltd. come from?
All FDA import refusal data for Fung Song Pharm Biotechnology 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.