Shiv Enterprises Exim Pvt Ltd
⚠️ Moderate Risk
FEI: 3006089222 • Mumbai, Maharashtra • INDIA
FEI Number
3006089222
Location
Mumbai, Maharashtra
Country
INDIAAddress
502, , Mumbai, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2009 | 53BD99OTHER BATH PREPARATIONS, N.E.C. | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 2/4/2009 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New York District Office (NYK-DO) | |
| 2/15/2008 | 53BD99OTHER BATH PREPARATIONS, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/15/2008 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/5/2008 | 07BGN06POTATO CHIPS,FRIED | 249FILTHY | New York District Office (NYK-DO) |
| 9/7/2007 | 37JCN99SAUCES, N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 9/6/2007 | 21TGH14TAMARIND, DRIED OR PASTE | 249FILTHY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shiv Enterprises Exim Pvt Ltd's FDA import refusal history?
Shiv Enterprises Exim Pvt Ltd (FEI: 3006089222) has 7 FDA import refusal record(s) in our database, spanning from 9/6/2007 to 2/4/2009.
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. Shiv Enterprises Exim Pvt Ltd's FEI number is 3006089222.
What types of violations has Shiv Enterprises Exim Pvt Ltd received?
Shiv Enterprises Exim Pvt Ltd has been cited for 4 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 Shiv Enterprises Exim Pvt Ltd come from?
All FDA import refusal data for Shiv Enterprises Exim Pvt 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.