Jilin Shulan Synthetic Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3003091092 • Jilin, Jilin • CHINA
FEI Number
3003091092
Location
Jilin, Jilin
Country
CHINAAddress
No. 2066 Peoples Main Road, Shulan, Jilin, Jilin, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2020 | 65QQT37AMINOPHYLLINE (RELAXANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2020 | 65QQT37AMINOPHYLLINE (RELAXANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2020 | 65QQT37AMINOPHYLLINE (RELAXANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2020 | 65QQT37AMINOPHYLLINE (RELAXANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 3/8/2018 | 63BQS30THEOPHYLLINE (BRONCHODILATOR) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 11/4/2011 | 45LG99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 8/24/2011 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 27DRUG GMPS | New York District Office (NYK-DO) |
| 8/12/2008 | 66BAY05CAFFEINE (STIMULANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jilin Shulan Synthetic Pharmaceutical Co. Ltd.'s FDA import refusal history?
Jilin Shulan Synthetic Pharmaceutical Co. Ltd. (FEI: 3003091092) has 8 FDA import refusal record(s) in our database, spanning from 8/12/2008 to 9/8/2020.
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. Jilin Shulan Synthetic Pharmaceutical Co. Ltd.'s FEI number is 3003091092.
What types of violations has Jilin Shulan Synthetic Pharmaceutical Co. Ltd. received?
Jilin Shulan Synthetic 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 Jilin Shulan Synthetic Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Jilin Shulan Synthetic 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.