Macleods Pharmaceuticals Ltd
⚠️ High Risk
FEI: 3007013286 • Mumbai, Maharashtra • INDIA
FEI Number
3007013286
Location
Mumbai, Maharashtra
Country
INDIAAddress
304 Atlanta Arcade, Church Road, Mumbai, Maharashtra, 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 |
|---|---|---|---|
| 12/1/2025 | 62JDY99ANTI-PARKINSONIAN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 62CDY68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2024 | 64LCA50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 62UDL99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2023 | 64LCK50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 56CDB65CEFPROZIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2023 | 61XDA37TRIPROLIDINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2023 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2023 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2021 | 62GIS42INDOMETHACIN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 8/9/2021 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 61JCA03DEXTROTHYROXINE SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2021 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 64LCY50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 60LCA82PHENAZOPYRIDINE HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2018 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 60CDB45METIZOLINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 10/12/2017 | 60CDB45METIZOLINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 7/26/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/20/2016 | 65NDC76THYROXINE I 125 (RADIOACTIVE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2016 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/12/2016 | 62OIY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/14/2005 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Macleods Pharmaceuticals Ltd's FDA import refusal history?
Macleods Pharmaceuticals Ltd (FEI: 3007013286) has 30 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 12/1/2025.
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 Ltd's FEI number is 3007013286.
What types of violations has Macleods Pharmaceuticals Ltd received?
Macleods 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 Macleods Pharmaceuticals Ltd come from?
All FDA import refusal data for Macleods 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.