Malladi Drugs & Pharmaceuticals Ltd
⚠️ Moderate Risk
FEI: 3002780785 • Vellore, Tamil Nadu • INDIA
FEI Number
3002780785
Location
Vellore, Tamil Nadu
Country
INDIAAddress
No. 7b & 7c Sipcot Industrial Complex, , Ranipet, Vellore, Tamil Nadu, 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
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).
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 |
|---|---|---|---|
| 3/15/2016 | 60CQS10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 12/10/2014 | 60CAS10PSEUDOEPHEDRINE HCL (ADRENERGIC) | Chicago District Office (CHI-DO) | |
| 6/7/2005 | 61XBS08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/7/2005 | 64HBS08BROMPHENIRAMINE/DM HBR/PSEUDOEPHEDRINE (EXPECTORANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/7/2005 | 64HBS08BROMPHENIRAMINE/DM HBR/PSEUDOEPHEDRINE (EXPECTORANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/7/2005 | 62UDS99ANTI-TUSSIVE/COLD N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/7/2005 | 62UDS99ANTI-TUSSIVE/COLD N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 60CBS99ADRENERGIC N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 60CBS99ADRENERGIC N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 64HBS08BROMPHENIRAMINE/DM HBR/PSEUDOEPHEDRINE (EXPECTORANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 64HBS08BROMPHENIRAMINE/DM HBR/PSEUDOEPHEDRINE (EXPECTORANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/25/2005 | 60CBS99ADRENERGIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Malladi Drugs & Pharmaceuticals Ltd's FDA import refusal history?
Malladi Drugs & Pharmaceuticals Ltd (FEI: 3002780785) has 12 FDA import refusal record(s) in our database, spanning from 2/25/2005 to 3/15/2016.
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. Malladi Drugs & Pharmaceuticals Ltd's FEI number is 3002780785.
What types of violations has Malladi Drugs & Pharmaceuticals Ltd received?
Malladi Drugs & Pharmaceuticals 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 Malladi Drugs & Pharmaceuticals Ltd come from?
All FDA import refusal data for Malladi Drugs & Pharmaceuticals 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.