Guilin China Resources Tianhe Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003704959 • Guilin, Guangxi Zhuang Autonomous Regi • CHINA
FEI Number
3003704959
Location
Guilin, Guangxi Zhuang Autonomous Regi
Country
CHINAAddress
Lushan Industrial Park, 1 Lushan Road; Linguixian, Guilin, Guangxi Zhuang Autonomous Regi, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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
Frequently Asked Questions
What is Guilin China Resources Tianhe Pharmaceutical Co., Ltd.'s FDA import refusal history?
Guilin China Resources Tianhe Pharmaceutical Co., Ltd. (FEI: 3003704959) has 2 FDA import refusal record(s) in our database, spanning from 8/6/2004 to 3/7/2013.
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. Guilin China Resources Tianhe Pharmaceutical Co., Ltd.'s FEI number is 3003704959.
What types of violations has Guilin China Resources Tianhe Pharmaceutical Co., Ltd. received?
Guilin China Resources Tianhe Pharmaceutical 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 Guilin China Resources Tianhe Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Guilin China Resources Tianhe Pharmaceutical 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.