PINNACLE CO., LTD

⚠️ Moderate Risk

FEI: 3006946173 • Zibo, Shandong • CHINA

FEI

FEI Number

3006946173

📍

Location

Zibo, Shandong

🇨🇳

Country

CHINA

🏢

Address

Lot 2, No. 21 Qingtian Road, Qilu Chemical Industrial Park, Linzi, Zibo, Shandong, China

Moderate Risk

FDA Import Risk Assessment

45.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/20/2023

Latest Refusal

9/29/2008

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

41.3×30%

Recency

41.3×20%

Frequency

8.0×10%

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

Violation Summary

4779×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
10/20/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
10/20/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
10/20/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
8/1/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
2/10/2009	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
2/10/2009	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
2/9/2009	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Philadelphia District Office (PHI-DO)
2/9/2009	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Philadelphia District Office (PHI-DO)
2/9/2009	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Philadelphia District Office (PHI-DO)
9/29/2008	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED	Los Angeles District Office (LOS-DO)
9/29/2008	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED	Los Angeles District Office (LOS-DO)
9/29/2008	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is PINNACLE CO., LTD's FDA import refusal history?

PINNACLE CO., LTD (FEI: 3006946173) has 12 FDA import refusal record(s) in our database, spanning from 9/29/2008 to 10/20/2023.

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. PINNACLE CO., LTD's FEI number is 3006946173.

What types of violations has PINNACLE CO., LTD received?

PINNACLE 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 PINNACLE CO., LTD come from?

All FDA import refusal data for PINNACLE 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.