Shanghai Record Pharmaceuticals Co., Ltd.
⚠️ Moderate Risk
FEI: 3004870616 • Shanghai, Shanghai • CHINA
FEI Number
3004870616
Location
Shanghai, Shanghai
Country
CHINAAddress
2/F and 3/F, Building 1, 1299 Ziyue Road,, , Minghai, 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
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2014 | 60EQT01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | Southwest Import District Office (SWI-DO) | |
| 9/26/2012 | 60ECT01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 72NEW VET DR | Atlanta District Office (ATL-DO) |
| 8/6/2009 | 60EAS01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/17/2008 | 60ECS01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/17/2008 | 60ECS01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/29/2007 | 60ECS01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Shanghai Record Pharmaceuticals Co., Ltd.'s FDA import refusal history?
Shanghai Record Pharmaceuticals Co., Ltd. (FEI: 3004870616) has 6 FDA import refusal record(s) in our database, spanning from 6/29/2007 to 6/11/2014.
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 Record Pharmaceuticals Co., Ltd.'s FEI number is 3004870616.
What types of violations has Shanghai Record Pharmaceuticals Co., Ltd. received?
Shanghai Record Pharmaceuticals Co., Ltd. has been cited for 3 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 Record Pharmaceuticals Co., Ltd. come from?
All FDA import refusal data for Shanghai Record Pharmaceuticals 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.