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Hesh Herbal PVT LTD

⚠️ Moderate Risk

FEI: 2000004335 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

2000004335

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Singh Industrial Estate No 1, C/14 Ram Mandir Road, Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

42.7
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
6/4/2011
Latest Refusal
1/23/2004
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
6.8×10%
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

755×

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).

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
6/4/2011
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
6/4/2011
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
6/4/2011
66VAR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/24/2010
53EH99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/23/2004
66VCR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Hesh Herbal PVT LTD's FDA import refusal history?

Hesh Herbal PVT LTD (FEI: 2000004335) has 5 FDA import refusal record(s) in our database, spanning from 1/23/2004 to 6/4/2011.

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. Hesh Herbal PVT LTD's FEI number is 2000004335.

What types of violations has Hesh Herbal PVT LTD received?

Hesh Herbal PVT 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 Hesh Herbal PVT LTD come from?

All FDA import refusal data for Hesh Herbal PVT 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.