Macleods Pharmaceuticals
⚠️ High Risk
FEI: 3012367935 • Ranipool, Sikkim • INDIA
FEI Number
3012367935
Location
Ranipool, Sikkim
Country
INDIAAddress
Khasra No 21, 22, 66, 67, 68 Aho-Yangtam, Namchepung, , Ranipool, Sikkim, 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 |
|---|---|---|---|
| 12/8/2025 | 61PCY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 11/6/2025 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2025 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 60SCA99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2025 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2024 | 61WDY52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2024 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Northeast Imports (DNEI) | |
| 11/6/2020 | 61GCA85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2019 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2019 | 66QDA99URICOSURIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2019 | 60SDY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Macleods Pharmaceuticals's FDA import refusal history?
Macleods Pharmaceuticals (FEI: 3012367935) has 12 FDA import refusal record(s) in our database, spanning from 10/24/2019 to 12/8/2025.
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's FEI number is 3012367935.
What types of violations has Macleods Pharmaceuticals received?
Macleods Pharmaceuticals 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 come from?
All FDA import refusal data for Macleods Pharmaceuticals 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.