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Nitya International

⚠️ High Risk

FEI: 3003777201 • Allahabad • INDIA

FEI

FEI Number

3003777201

📍

Location

Allahabad

🇮🇳

Country

INDIA
🏢

Address

15-B Sarojini Naidu Marg, , Allahabad, , India

High Risk

FDA Import Risk Assessment

64.9
LowModerateHighCritical

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

Statistics

55
Total Refusals
3
Unique Violations
3/4/2009
Latest Refusal
6/20/2005
Earliest Refusal

Score Breakdown

Violation Severity
88.6×40%
Refusal Volume
64.8×30%
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

7555×

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).

21208×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/4/2009
66VY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/4/2009
66VY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/29/2007
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
83NO PROCESS
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66B99STIMULANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Nitya International's FDA import refusal history?

Nitya International (FEI: 3003777201) has 55 FDA import refusal record(s) in our database, spanning from 6/20/2005 to 3/4/2009.

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. Nitya International's FEI number is 3003777201.

What types of violations has Nitya International received?

Nitya International has been cited for 3 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 Nitya International come from?

All FDA import refusal data for Nitya International 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.