Maneesha Agencies

⚠️ Moderate Risk

FEI: 1000325291 • Pune, Maharashtra • INDIA

FEI

FEI Number

1000325291

📍

Location

Pune, Maharashtra

🇮🇳

Country

INDIA

🏢

Address

1293, , Pune, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

43.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/5/2011

Latest Refusal

4/21/2004

Earliest Refusal

Score Breakdown

Violation Severity

70.7×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

19.2×10%

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

Violation Summary

7514×

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).

11813×

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

Date	Product	Violations	Division
8/5/2011	41YFY99DIETARY CONVENTIONAL FOODS, N.E.C.	75UNAPPROVED	New Orleans District Office (NOL-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
4/21/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Maneesha Agencies's FDA import refusal history?

Maneesha Agencies (FEI: 1000325291) has 14 FDA import refusal record(s) in our database, spanning from 4/21/2004 to 8/5/2011.

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. Maneesha Agencies's FEI number is 1000325291.

What types of violations has Maneesha Agencies received?

Maneesha Agencies 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 Maneesha Agencies come from?

All FDA import refusal data for Maneesha Agencies 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.