Guangzhou Baiyunshan Pharmaceutical Factory
⚠️ Moderate Risk
FEI: 3006532121 • Guangzhou, Guangdong • CHINA
FEI Number
3006532121
Location
Guangzhou, Guangdong
Country
CHINAAddress
No. 88 Yunxiang Road, Tonghe Street, Baiyun District, Guangzhou, Guangdong, 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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2023 | 61XDE08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 4/30/2014 | 60LBY99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/27/2014 | 60LBY99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/16/2012 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/22/2011 | 95RDZLOW-POWER LASER LIGHT SHOW PROJECTOR, DISPLAY PRODUCTS | 476NO REGISTR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Guangzhou Baiyunshan Pharmaceutical Factory's FDA import refusal history?
Guangzhou Baiyunshan Pharmaceutical Factory (FEI: 3006532121) has 5 FDA import refusal record(s) in our database, spanning from 11/22/2011 to 10/3/2023.
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. Guangzhou Baiyunshan Pharmaceutical Factory's FEI number is 3006532121.
What types of violations has Guangzhou Baiyunshan Pharmaceutical Factory received?
Guangzhou Baiyunshan Pharmaceutical Factory has been cited for 5 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 Guangzhou Baiyunshan Pharmaceutical Factory come from?
All FDA import refusal data for Guangzhou Baiyunshan Pharmaceutical Factory 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.