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HERBAL MAZA DRUG COMPANY

⚠️ High Risk

FEI: 3017171026 • Muzaffarnagar, Uttar Pradesh • INDIA

FEI

FEI Number

3017171026

📍

Location

Muzaffarnagar, Uttar Pradesh

🇮🇳

Country

INDIA
🏢

Address

855/28 Amba Vihar, Pole No 125, Muzaffarnagar, Uttar Pradesh, India

High Risk

FDA Import Risk Assessment

52.2
LowModerateHighCritical

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

Statistics

10
Total Refusals
2
Unique Violations
2/3/2021
Latest Refusal
10/23/2020
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7510×

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).

1185×

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
2/3/2021
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/3/2021
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/3/2021
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/3/2021
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/3/2021
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/22/2021
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/23/2020
66VDE99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/23/2020
66VDE99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/23/2020
66VDE99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/23/2020
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HERBAL MAZA DRUG COMPANY's FDA import refusal history?

HERBAL MAZA DRUG COMPANY (FEI: 3017171026) has 10 FDA import refusal record(s) in our database, spanning from 10/23/2020 to 2/3/2021.

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. HERBAL MAZA DRUG COMPANY's FEI number is 3017171026.

What types of violations has HERBAL MAZA DRUG COMPANY received?

HERBAL MAZA DRUG COMPANY 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 HERBAL MAZA DRUG COMPANY come from?

All FDA import refusal data for HERBAL MAZA DRUG COMPANY 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.