Shalaks Pharmaceuticals Pvt Ltd
⚠️ High Risk
FEI: 3007844890 • New Delhi • INDIA
FEI Number
3007844890
Location
New Delhi
Country
INDIAAddress
C-3,Puja House Karampura Community Centr, , New Delhi, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/30/2009 | 62JBB18SELEGILINE HYDROCHLORIDE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 61NAB74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 64GCB19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 64XAJ12TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 65KCL10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 56JBL21CLINDAMYCIN PALMITATE HYDROCHLORIDE (LINCOMYCINS) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 61WBJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 63VAL02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/30/2009 | 62CAL41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Shalaks Pharmaceuticals Pvt Ltd's FDA import refusal history?
Shalaks Pharmaceuticals Pvt Ltd (FEI: 3007844890) has 9 FDA import refusal record(s) in our database, spanning from 9/30/2009 to 9/30/2009.
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. Shalaks Pharmaceuticals Pvt Ltd's FEI number is 3007844890.
What types of violations has Shalaks Pharmaceuticals Pvt Ltd received?
Shalaks Pharmaceuticals Pvt Ltd has been cited for 1 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 Shalaks Pharmaceuticals Pvt Ltd come from?
All FDA import refusal data for Shalaks Pharmaceuticals 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.