ImportRefusal LogoImportRefusal

Prep International

⚠️ Moderate Risk

FEI: 3004766003 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3004766003

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

179/11 Olympus Building, 1st Floor, Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

35.6
LowModerateHighCritical

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

Statistics

12
Total Refusals
3
Unique Violations
8/4/2006
Latest Refusal
3/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
51.3×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
27.4×10%
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

11810×

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).

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

752×

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
8/4/2006
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
3/7/2006
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/27/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/14/2003
85HHLPAD, MENSTRUAL, SCENTED
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
2/14/2003
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)
3/18/2002
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Prep International's FDA import refusal history?

Prep International (FEI: 3004766003) has 12 FDA import refusal record(s) in our database, spanning from 3/18/2002 to 8/4/2006.

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. Prep International's FEI number is 3004766003.

What types of violations has Prep International received?

Prep 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 Prep International come from?

All FDA import refusal data for Prep 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.