Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004475606 • Shanghai, Shanghai • CHINA
FEI Number
3004475606
Location
Shanghai, Shanghai
Country
CHINAAddress
1317 Jianchuanlu, Minhang District, Shanghai, Shanghai, 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
REDUCED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.
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).
Refusal History
Frequently Asked Questions
What is Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.'s FDA import refusal history?
Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd. (FEI: 3004475606) has 2 FDA import refusal record(s) in our database, spanning from 6/24/2008 to 6/24/2008.
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. Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.'s FEI number is 3004475606.
What types of violations has Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd. received?
Shanghai No. 1 Biochemical & Pharmaceutical 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 Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Shanghai No. 1 Biochemical & 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.