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KEMIKO PHARMACEUTICALS LTD

⚠️ High Risk

FEI: 3012902362 • Dhaka • BANGLADESH

FEI

FEI Number

3012902362

📍

Location

Dhaka

🇧🇩

Country

BANGLADESH
🏢

Address

G.P.O., 338 Segunbagicha 34 Kem, Dhaka, , Bangladesh

High Risk

FDA Import Risk Assessment

51.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
11/21/2016
Latest Refusal
11/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

756×

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).

Refusal History

DateProductViolationsDivision
11/21/2016
60SCA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/21/2016
61XCA51LEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/21/2016
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/21/2016
62GDA50NAPROXEN SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/21/2016
56CCA54CEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/21/2016
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is KEMIKO PHARMACEUTICALS LTD's FDA import refusal history?

KEMIKO PHARMACEUTICALS LTD (FEI: 3012902362) has 6 FDA import refusal record(s) in our database, spanning from 11/21/2016 to 11/21/2016.

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. KEMIKO PHARMACEUTICALS LTD's FEI number is 3012902362.

What types of violations has KEMIKO PHARMACEUTICALS LTD received?

KEMIKO PHARMACEUTICALS LTD 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 KEMIKO PHARMACEUTICALS LTD come from?

All FDA import refusal data for KEMIKO PHARMACEUTICALS 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.