Keval Exports Pvt. Ltd
⚠️ High Risk
FEI: 3011644133 • Mumbai • INDIA
FEI Number
3011644133
Location
Mumbai
Country
INDIAAddress
401, 4th Floor, The Ambience Court Plot, , Mumbai, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
POISONORD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:
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).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2024 | 21UCT14TAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | 249FILTHY | Division of Southwest Imports (DSWI) |
| 2/27/2024 | 27VCI99VINEGAR, N.E.C. | Division of Southwest Imports (DSWI) | |
| 2/27/2024 | 27VCI99VINEGAR, N.E.C. | Division of Southwest Imports (DSWI) | |
| 2/27/2024 | 27VCI99VINEGAR, N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/13/2023 | 23BGT14BETEL NUT, SHELLED | Division of Northeast Imports (DNEI) | |
| 12/13/2022 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/30/2022 | 21THT14TAMARIND, DRIED OR PASTE | 249FILTHY | Division of Southwest Imports (DSWI) |
| 7/27/2021 | 21SGT14TAMARIND (SUBTROPICAL AND TROPICAL FRUIT) | 249FILTHY | Division of Southwest Imports (DSWI) |
| 7/27/2021 | 21SGT14TAMARIND (SUBTROPICAL AND TROPICAL FRUIT) | 249FILTHY | Division of Southwest Imports (DSWI) |
| 2/26/2018 | 28AGT54PEPPER,BLACK, WHOLE (SPICE) | Division of Northeast Imports (DNEI) | |
| 2/26/2018 | 28AGT54PEPPER,BLACK, WHOLE (SPICE) | Division of Northeast Imports (DNEI) | |
| 7/2/2015 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Keval Exports Pvt. Ltd's FDA import refusal history?
Keval Exports Pvt. Ltd (FEI: 3011644133) has 12 FDA import refusal record(s) in our database, spanning from 7/2/2015 to 2/27/2024.
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. Keval Exports Pvt. Ltd's FEI number is 3011644133.
What types of violations has Keval Exports Pvt. Ltd received?
Keval Exports Pvt. Ltd has been cited for 11 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 Keval Exports Pvt. Ltd come from?
All FDA import refusal data for Keval Exports 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.