Guangzhou Zhongke baishi Health Industry Co., Ltd.
⚠️ Moderate Risk
FEI: 3016706196 • Guangzhou, Guangdong • CHINA
FEI Number
3016706196
Location
Guangzhou, Guangdong
Country
CHINAAddress
Plant D, No.1l, Lane 4, Fengying, High-Tech Industrial Park, Conghua Economic Development Zone, Conghua 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 Guangzhou Zhongke baishi Health Industry Co., Ltd.'s FDA import refusal history?
Guangzhou Zhongke baishi Health Industry Co., Ltd. (FEI: 3016706196) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2020 to 12/29/2020.
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 Zhongke baishi Health Industry Co., Ltd.'s FEI number is 3016706196.
What types of violations has Guangzhou Zhongke baishi Health Industry Co., Ltd. received?
Guangzhou Zhongke baishi Health Industry Co., Ltd. has been cited for 4 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 Zhongke baishi Health Industry Co., Ltd. come from?
All FDA import refusal data for Guangzhou Zhongke baishi Health Industry 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.