Charak Pharma Pvt. Ltd
⚠️ Moderate Risk
FEI: 3004701158 • Panipat, Haryana • INDIA
FEI Number
3004701158
Location
Panipat, Haryana
Country
INDIAAddress
Jaurasi Road, Pauti Village, G.T. Road, Samalkha, Panipat, Haryana, 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).
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2017 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2013 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/23/2010 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/30/2004 | 60LBA99ANALGESIC, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Charak Pharma Pvt. Ltd's FDA import refusal history?
Charak Pharma Pvt. Ltd (FEI: 3004701158) has 4 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 7/27/2017.
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. Charak Pharma Pvt. Ltd's FEI number is 3004701158.
What types of violations has Charak Pharma Pvt. Ltd received?
Charak Pharma 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 Charak Pharma Pvt. Ltd come from?
All FDA import refusal data for Charak Pharma 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.