Sinopep Pharmaceutical Inc.
⚠️ Moderate Risk
FEI: 3005435899 • Hangzhou, Zhejiang • CHINA
FEI Number
3005435899
Location
Hangzhou, Zhejiang
Country
CHINAAddress
1180 Binanlu, Binjiang, Hangzhou, Zhejiang, 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.
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).
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 |
|---|---|---|---|
| 5/19/2009 | 65DCR99OXYTOCIC N.E.C. | Seattle District Office (SEA-DO) | |
| 5/1/2006 | 56FCR99PEPTIDE N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/6/2005 | 65DCZ06OXYTOCIN (INJECTION) (OXYTOCIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Sinopep Pharmaceutical Inc.'s FDA import refusal history?
Sinopep Pharmaceutical Inc. (FEI: 3005435899) has 3 FDA import refusal record(s) in our database, spanning from 12/6/2005 to 5/19/2009.
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. Sinopep Pharmaceutical Inc.'s FEI number is 3005435899.
What types of violations has Sinopep Pharmaceutical Inc. received?
Sinopep Pharmaceutical Inc. 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 Sinopep Pharmaceutical Inc. come from?
All FDA import refusal data for Sinopep Pharmaceutical Inc. 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.