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AMKETTE ANALYTICS LTD

⚠️ Moderate Risk

FEI: 3013613806 • Umargam, Gujarat • INDIA

FEI

FEI Number

3013613806

📍

Location

Umargam, Gujarat

🇮🇳

Country

INDIA
🏢

Address

Plot No 210gidc Ind Area, , Umargam, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
3/3/2020
Latest Refusal
3/3/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3416×

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).

5086×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/3/2020
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Division of Northeast Imports (DNEI)
3/3/2020
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Division of Northeast Imports (DNEI)
3/3/2020
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Division of Northeast Imports (DNEI)
3/3/2020
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Division of Northeast Imports (DNEI)
3/3/2020
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Division of Northeast Imports (DNEI)
3/3/2020
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is AMKETTE ANALYTICS LTD's FDA import refusal history?

AMKETTE ANALYTICS LTD (FEI: 3013613806) has 6 FDA import refusal record(s) in our database, spanning from 3/3/2020 to 3/3/2020.

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. AMKETTE ANALYTICS LTD's FEI number is 3013613806.

What types of violations has AMKETTE ANALYTICS LTD received?

AMKETTE ANALYTICS 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 AMKETTE ANALYTICS LTD come from?

All FDA import refusal data for AMKETTE ANALYTICS 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.