Shinpharma Inc.
⚠️ Moderate Risk
FEI: 3012274596 • Surrey, British Columbia • CANADA
FEI Number
3012274596
Location
Surrey, British Columbia
Country
CANADAAddress
12920 84 Ave, , Surrey, British Columbia, Canada
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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2016 | 60QBY40LIDOCAINE HCL (ANESTHETIC) | 336INCONSPICU | Cincinnati District Office (CIN-DO) |
| 7/15/2016 | 60QAJ67LIDOCAINE (ANESTHETIC) | Seattle District Office (SEA-DO) | |
| 7/12/2016 | 60QBY67LIDOCAINE (ANESTHETIC) | Cincinnati District Office (CIN-DO) | |
| 7/6/2016 | 60QKO67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/17/2016 | 60QBY67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/13/2016 | 60QKO67LIDOCAINE (ANESTHETIC) | Seattle District Office (SEA-DO) | |
| 5/20/2016 | 60QAJ67LIDOCAINE (ANESTHETIC) | Seattle District Office (SEA-DO) | |
| 4/14/2016 | 60QAJ67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Shinpharma Inc.'s FDA import refusal history?
Shinpharma Inc. (FEI: 3012274596) has 8 FDA import refusal record(s) in our database, spanning from 4/14/2016 to 8/9/2016.
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. Shinpharma Inc.'s FEI number is 3012274596.
What types of violations has Shinpharma Inc. received?
Shinpharma Inc. has been cited for 5 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 Shinpharma Inc. come from?
All FDA import refusal data for Shinpharma 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.