ImportRefusal LogoImportRefusal

MANISHA AGENCY

⚠️ High Risk

FEI: 3004685390 • Pune, Maharashtra • INDIA

FEI

FEI Number

3004685390

📍

Location

Pune, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

36 Opp Mhatoba Mandir, , Pune, Maharashtra, India

High Risk

FDA Import Risk Assessment

60.8
LowModerateHighCritical

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

Statistics

111
Total Refusals
2
Unique Violations
11/5/2008
Latest Refusal
11/1/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
75.9×30%
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

118111×

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).

75111×

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
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/5/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2008
54FBB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is MANISHA AGENCY's FDA import refusal history?

MANISHA AGENCY (FEI: 3004685390) has 111 FDA import refusal record(s) in our database, spanning from 11/1/2008 to 11/5/2008.

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. MANISHA AGENCY's FEI number is 3004685390.

What types of violations has MANISHA AGENCY received?

MANISHA AGENCY 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 MANISHA AGENCY come from?

All FDA import refusal data for MANISHA AGENCY 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.