Bing Han Pharmaceutical Factory Co., Ltd.
⚠️ Moderate Risk
FEI: 3004347309 • Tainan, Tainan - Municipality • TAIWAN
FEI Number
3004347309
Location
Tainan, Tainan - Municipality
Country
TAIWANAddress
Kuan Tyen Hsiang, 81 Cheng Kung St., Tainan, Tainan - Municipality, Taiwan
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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2007 | 54FBR12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 2920PESTICIDES | Seattle District Office (SEA-DO) |
| 1/30/2004 | 54FBH12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Seattle District Office (SEA-DO) | |
| 1/30/2004 | 54FBH12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Seattle District Office (SEA-DO) | |
| 5/2/2003 | 54YBZ04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 2920PESTICIDES | Cincinnati District Office (CIN-DO) |
| 8/20/2002 | 54FBT12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Bing Han Pharmaceutical Factory Co., Ltd.'s FDA import refusal history?
Bing Han Pharmaceutical Factory Co., Ltd. (FEI: 3004347309) has 5 FDA import refusal record(s) in our database, spanning from 8/20/2002 to 12/7/2007.
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. Bing Han Pharmaceutical Factory Co., Ltd.'s FEI number is 3004347309.
What types of violations has Bing Han Pharmaceutical Factory Co., Ltd. received?
Bing Han Pharmaceutical Factory Co., Ltd. has been cited for 6 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 Bing Han Pharmaceutical Factory Co., Ltd. come from?
All FDA import refusal data for Bing Han Pharmaceutical Factory 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.