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SUZHOU APAC PHARMATECH CO LTD

✅ Low Risk

FEI: 3012633326 • Suzhou • CHINA

FEI

FEI Number

3012633326

📍

Location

Suzhou

🇨🇳

Country

CHINA
🏢

Address

2358 Changan Road Floor, , Suzhou, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
4/19/2018
Latest Refusal
4/19/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

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.

4721×

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
4/19/2018
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
16DIRECTIONS
472NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SUZHOU APAC PHARMATECH CO LTD's FDA import refusal history?

SUZHOU APAC PHARMATECH CO LTD (FEI: 3012633326) has 1 FDA import refusal record(s) in our database, spanning from 4/19/2018 to 4/19/2018.

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. SUZHOU APAC PHARMATECH CO LTD's FEI number is 3012633326.

What types of violations has SUZHOU APAC PHARMATECH CO LTD received?

SUZHOU APAC PHARMATECH 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 SUZHOU APAC PHARMATECH CO LTD come from?

All FDA import refusal data for SUZHOU APAC PHARMATECH 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.