ImportRefusal LogoImportRefusal

Shanghai STA Pharmaceutical Product Co., Ltd.

⚠️ High Risk

FEI: 3014310427 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3014310427

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

31 Yiwei Road, Trade Zone, Shanghai, Shanghai, China

High Risk

FDA Import Risk Assessment

57.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
1
Unique Violations
12/13/2023
Latest Refusal
11/23/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
44.0×20%
Frequency
29.2×10%
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

756×

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

DateProductViolationsDivision
12/13/2023
60TIB99ANTAGONIST, N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/13/2023
60TIB99ANTAGONIST, N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/13/2023
60TIB99ANTAGONIST, N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
2/17/2023
62GIA99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
11/23/2021
66YIA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)
11/23/2021
66YIA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Shanghai STA Pharmaceutical Product Co., Ltd.'s FDA import refusal history?

Shanghai STA Pharmaceutical Product Co., Ltd. (FEI: 3014310427) has 6 FDA import refusal record(s) in our database, spanning from 11/23/2021 to 12/13/2023.

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 STA Pharmaceutical Product Co., Ltd.'s FEI number is 3014310427.

What types of violations has Shanghai STA Pharmaceutical Product Co., Ltd. received?

Shanghai STA Pharmaceutical Product Co., Ltd. has been cited for 1 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 STA Pharmaceutical Product Co., Ltd. come from?

All FDA import refusal data for Shanghai STA Pharmaceutical Product 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.