Guangzhou Cikang Biotechnology Co., Ltd.
⚠️ Moderate Risk
FEI: 3016777608 • Guangzhou, Guangdong • CHINA
FEI Number
3016777608
Location
Guangzhou, Guangdong
Country
CHINAAddress
Huadu Dist., No. 3 Longhui Gongye Rd.; Huashan Town, 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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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 Cikang Biotechnology Co., Ltd.'s FDA import refusal history?
Guangzhou Cikang Biotechnology Co., Ltd. (FEI: 3016777608) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2020 to 10/28/2020.
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 Cikang Biotechnology Co., Ltd.'s FEI number is 3016777608.
What types of violations has Guangzhou Cikang Biotechnology Co., Ltd. received?
Guangzhou Cikang Biotechnology Co., Ltd. has been cited for 2 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 Cikang Biotechnology Co., Ltd. come from?
All FDA import refusal data for Guangzhou Cikang Biotechnology 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.