Cheminnova Remedies Pvt. Ltd
⚠️ Moderate Risk
FEI: 3005593764 • Medak • INDIA
FEI Number
3005593764
Location
Medak
Country
INDIAAddress
Unit - II, 8-23, SVCIE, Sy.No:296/7/6, I.D.A.Bollaram, Medak, , 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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2011 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/26/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/17/2011 | 60SDL99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 3/23/2011 | 61VBL99ANTI-FLATULENT N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/5/2011 | 61VBL99ANTI-FLATULENT N.E.C. | New York District Office (NYK-DO) | |
| 7/14/2010 | 65RBL18SODIUM BICARBONATE (REPLENISHER) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/1/2009 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/6/2006 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/2/2006 | 60SBK99ANTACID, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Cheminnova Remedies Pvt. Ltd's FDA import refusal history?
Cheminnova Remedies Pvt. Ltd (FEI: 3005593764) has 9 FDA import refusal record(s) in our database, spanning from 5/2/2006 to 6/3/2011.
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. Cheminnova Remedies Pvt. Ltd's FEI number is 3005593764.
What types of violations has Cheminnova Remedies Pvt. Ltd received?
Cheminnova Remedies Pvt. 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 Cheminnova Remedies Pvt. Ltd come from?
All FDA import refusal data for Cheminnova Remedies 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.