CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd
⚠️ Moderate Risk
FEI: 3005892317 • Shijiazhuang, Hebei • CHINA
FEI Number
3005892317
Location
Shijiazhuang, Hebei
Country
CHINAAddress
No. 188 Gongnong Road, , Shijiazhuang, Hebei, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2015 | 56BAY52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/27/2010 | 56AAA10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2010 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd's FDA import refusal history?
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd (FEI: 3005892317) has 3 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 12/2/2015.
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. CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd's FEI number is 3005892317.
What types of violations has CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd received?
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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 CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd come from?
All FDA import refusal data for CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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.