Yunnan Baiyao Group Co., Ltd.
⚠️ High Risk
FEI: 3005849524 • Kunming, Yunnan • CHINA
FEI Number
3005849524
Location
Kunming, Yunnan
Country
CHINAAddress
No. 3686 Yunnan Baiyao Street, Chenggong, Kunming, Yunnan, China
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
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).
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).
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/16/2025 | 62FBY99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 3/7/2025 | 62FBQ99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 3/7/2025 | 62FBQ99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 3/7/2025 | 62FBQ99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 3/7/2025 | 62FBQ99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 3/7/2025 | 62FBY99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 3/7/2025 | 62FBY99ANTI-INFECTIVE, TOPICAL N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 5/9/2023 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 6/22/2020 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2019 | 60LBQ99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/2/2015 | 66YDH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/2/2015 | 66YDR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/4/2012 | 60LBL99ANALGESIC, N.E.C. | 223FALSE | San Francisco District Office (SAN-DO) |
| 3/2/2012 | 60LBL99ANALGESIC, N.E.C. | 223FALSE | San Francisco District Office (SAN-DO) |
| 8/17/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 10/22/2003 | 79KMFBANDAGE, LIQUID | Los Angeles District Office (LOS-DO) | |
| 10/22/2003 | 79KMFBANDAGE, LIQUID | Los Angeles District Office (LOS-DO) | |
| 10/22/2003 | 80LDQDEVICE, GENERAL MEDICAL | Los Angeles District Office (LOS-DO) | |
| 10/22/2003 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 10/22/2003 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 10/22/2003 | 60LBL99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/22/2003 | 60LBQ99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/22/2003 | 60LBY99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/22/2003 | 60LBY99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Yunnan Baiyao Group Co., Ltd.'s FDA import refusal history?
Yunnan Baiyao Group Co., Ltd. (FEI: 3005849524) has 24 FDA import refusal record(s) in our database, spanning from 10/22/2003 to 4/16/2025.
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 Baiyao Group Co., Ltd.'s FEI number is 3005849524.
What types of violations has Yunnan Baiyao Group Co., Ltd. received?
Yunnan Baiyao Group Co., Ltd. has been cited for 7 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 Baiyao Group Co., Ltd. come from?
All FDA import refusal data for Yunnan Baiyao Group 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.