ImportRefusal LogoImportRefusal

Labotech Microscopes India Private Limited

✅ Low Risk

FEI: 3005527296 • Ambala Cantt, Haryana • INDIA

FEI

FEI Number

3005527296

📍

Location

Ambala Cantt, Haryana

🇮🇳

Country

INDIA
🏢

Address

19, HSIIDC INDUSTRIAL AREA, Ambala Cantt, Haryana, India

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
1
Unique Violations
11/29/2018
Latest Refusal
11/29/2018
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
11/29/2018
86HKOREFRACTOMETER, OPHTHALMIC
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Labotech Microscopes India Private Limited's FDA import refusal history?

Labotech Microscopes India Private Limited (FEI: 3005527296) has 1 FDA import refusal record(s) in our database, spanning from 11/29/2018 to 11/29/2018.

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. Labotech Microscopes India Private Limited's FEI number is 3005527296.

What types of violations has Labotech Microscopes India Private Limited received?

Labotech Microscopes India Private Limited has been cited for 1 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 Labotech Microscopes India Private Limited come from?

All FDA import refusal data for Labotech Microscopes India Private Limited 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.