Pravinchandra Jethalal & Co
⚠️ Moderate Risk
FEI: 3004281033 • Mumbai, Maharashtra • INDIA
FEI Number
3004281033
Location
Mumbai, Maharashtra
Country
INDIAAddress
506 Chamber Of Commerce Lane, Near Masjid Rly Station, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2008 | 29BGY99CARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 7/10/2007 | 60LBJ99ANALGESIC, N.E.C. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 7/10/2007 | 60LBJ99ANALGESIC, N.E.C. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 7/10/2007 | 60LBJ99ANALGESIC, N.E.C. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 7/10/2007 | 60LBJ99ANALGESIC, N.E.C. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 10/11/2002 | 50BFY60COLOR FOR COSMETIC (NOT CERTIFIED) | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 10/18/2001 | 60SBL09DIHYDROXYALUM SODIUM CARBONATE (ANTACID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pravinchandra Jethalal & Co's FDA import refusal history?
Pravinchandra Jethalal & Co (FEI: 3004281033) has 7 FDA import refusal record(s) in our database, spanning from 10/18/2001 to 12/19/2008.
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. Pravinchandra Jethalal & Co's FEI number is 3004281033.
What types of violations has Pravinchandra Jethalal & Co received?
Pravinchandra Jethalal & Co 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 Pravinchandra Jethalal & Co come from?
All FDA import refusal data for Pravinchandra Jethalal & Co 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.