Yunnan Panlong Yunhai Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3014146244 • Chuxiong, Yunnan • CHINA
FEI Number
3014146244
Location
Chuxiong, Yunnan
Country
CHINAAddress
# 270 Zixi Avenue, Development Zone, Chuxiong, Yunnan, 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
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
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
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/27/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/10/2009 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
| 2/19/2009 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/10/2009 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/5/2008 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/9/2004 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Yunnan Panlong Yunhai Pharmaceutical Co., Ltd.'s FDA import refusal history?
Yunnan Panlong Yunhai Pharmaceutical Co., Ltd. (FEI: 3014146244) has 14 FDA import refusal record(s) in our database, spanning from 11/9/2004 to 7/27/2017.
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. Yunnan Panlong Yunhai Pharmaceutical Co., Ltd.'s FEI number is 3014146244.
What types of violations has Yunnan Panlong Yunhai Pharmaceutical Co., Ltd. received?
Yunnan Panlong Yunhai 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 Yunnan Panlong Yunhai Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Yunnan Panlong Yunhai 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.