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Guangzhou Pinshang Biotechnology Development Co., Ltd.

⚠️ High Risk

FEI: 3016632239 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3016632239

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No.9 Fengying Road (Building 7), Guangdong Conghua Economic Development Zone,Conghua District, Guangzhou, Guangdong, China

High Risk

FDA Import Risk Assessment

51.2
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
7/22/2025
Latest Refusal
7/22/2025
Earliest Refusal

Score Breakdown

Violation Severity
66.0×40%
Refusal Volume
22.3×30%
Recency
75.8×20%
Frequency
30.0×10%
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

753×

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).

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
7/22/2025
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/22/2025
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/22/2025
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Guangzhou Pinshang Biotechnology Development Co., Ltd.'s FDA import refusal history?

Guangzhou Pinshang Biotechnology Development Co., Ltd. (FEI: 3016632239) has 3 FDA import refusal record(s) in our database, spanning from 7/22/2025 to 7/22/2025.

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. Guangzhou Pinshang Biotechnology Development Co., Ltd.'s FEI number is 3016632239.

What types of violations has Guangzhou Pinshang Biotechnology Development Co., Ltd. received?

Guangzhou Pinshang Biotechnology Development 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 Guangzhou Pinshang Biotechnology Development Co., Ltd. come from?

All FDA import refusal data for Guangzhou Pinshang Biotechnology Development 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.