Keshava Organics Private Ltd.
⚠️ Moderate Risk
FEI: 3003677831 • Tarapur, Maharashtra • INDIA
FEI Number
3003677831
Location
Tarapur, Maharashtra
Country
INDIAAddress
T - 97 98 & 100 Boisar, , Tarapur, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 1/6/2015 | 61XCS04BROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 1/6/2015 | 61XAS29PYRILAMINE MALEATE (ANTI-HISTAMINIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/4/2011 | 61XCS29PYRILAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/13/2010 | 61XCS04BROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Keshava Organics Private Ltd.'s FDA import refusal history?
Keshava Organics Private Ltd. (FEI: 3003677831) has 4 FDA import refusal record(s) in our database, spanning from 8/13/2010 to 1/6/2015.
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. Keshava Organics Private Ltd.'s FEI number is 3003677831.
What types of violations has Keshava Organics Private Ltd. received?
Keshava Organics Private Ltd. 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 Keshava Organics Private Ltd. come from?
All FDA import refusal data for Keshava Organics Private 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.