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Shenzhen Oriental Pharmaceutical Co Ltd

⚠️ Moderate Risk

FEI: 3003677845 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3003677845

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Long Gang, Longgangjiedao Longgang District, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

38.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
9/19/2013
Latest Refusal
2/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.6×10%
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

162×

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.

751×

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
9/19/2013
60CAR09PHENYLEPHRINE HCL (ADRENERGIC)
16DIRECTIONS
New York District Office (NYK-DO)
9/19/2013
60CAR09PHENYLEPHRINE HCL (ADRENERGIC)
16DIRECTIONS
New York District Office (NYK-DO)
2/16/2011
60CBS09PHENYLEPHRINE HCL (ADRENERGIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shenzhen Oriental Pharmaceutical Co Ltd's FDA import refusal history?

Shenzhen Oriental Pharmaceutical Co Ltd (FEI: 3003677845) has 3 FDA import refusal record(s) in our database, spanning from 2/16/2011 to 9/19/2013.

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. Shenzhen Oriental Pharmaceutical Co Ltd's FEI number is 3003677845.

What types of violations has Shenzhen Oriental Pharmaceutical Co Ltd received?

Shenzhen Oriental 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 Shenzhen Oriental Pharmaceutical Co Ltd come from?

All FDA import refusal data for Shenzhen Oriental 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.