Macleods Pharmaceuticals Limited
⚠️ High Risk
FEI: 3007517881 • District Solan, Himachal Pradesh • INDIA
FEI Number
3007517881
Location
District Solan, Himachal Pradesh
Country
INDIAAddress
Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan, Himachal Pradesh, 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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2025 | 66FCA05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2020 | 62FAB08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 62CCY68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2018 | 66SCA51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 56CDT64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2018 | 66SCB51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/19/2017 | 65QDY60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 61GCY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/16/2015 | 61EDY04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/17/2015 | 60TCA99ANTAGONIST, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/17/2014 | 64FCE99ENZYME INHIBITOR N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/14/2014 | 62GCA48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Macleods Pharmaceuticals Limited's FDA import refusal history?
Macleods Pharmaceuticals Limited (FEI: 3007517881) has 12 FDA import refusal record(s) in our database, spanning from 1/14/2014 to 4/8/2025.
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. Macleods Pharmaceuticals Limited's FEI number is 3007517881.
What types of violations has Macleods Pharmaceuticals Limited received?
Macleods Pharmaceuticals Limited 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 Macleods Pharmaceuticals Limited come from?
All FDA import refusal data for Macleods Pharmaceuticals Limited 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.