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Manisha Pharma Plast P. Ltd

⚠️ Moderate Risk

FEI: 3006544921 • Ranipur Haridwar • INDIA

FEI

FEI Number

3006544921

📍

Location

Ranipur Haridwar

🇮🇳

Country

INDIA
🏢

Address

Plot No. 4756 Sector-1b Sidcol, , Ranipur Haridwar, , India

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/7/2011
Latest Refusal
7/7/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
7/7/2011
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/7/2011
53LH03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
San Francisco District Office (SAN-DO)
7/7/2011
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Manisha Pharma Plast P. Ltd's FDA import refusal history?

Manisha Pharma Plast P. Ltd (FEI: 3006544921) has 3 FDA import refusal record(s) in our database, spanning from 7/7/2011 to 7/7/2011.

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. Manisha Pharma Plast P. Ltd's FEI number is 3006544921.

What types of violations has Manisha Pharma Plast P. Ltd received?

Manisha Pharma Plast P. 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 Manisha Pharma Plast P. Ltd come from?

All FDA import refusal data for Manisha Pharma Plast P. 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.