Medreich Limited
⚠️ High Risk
FEI: 3006448684 • Bangalore • INDIA
FEI Number
3006448684
Location
Bangalore
Country
INDIAAddress
12th Mile, Old Madras Road, , Bangalore, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2025 | 61HCA99ANTI-BACTERIAL, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/4/2025 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 56BDA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2024 | 56BBA07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/7/2023 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2022 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/11/2022 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2021 | 56KYA99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/30/2019 | 56YDY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2018 | 56BCH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/22/2018 | 61FDE30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/8/2018 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2016 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Medreich Limited's FDA import refusal history?
Medreich Limited (FEI: 3006448684) has 16 FDA import refusal record(s) in our database, spanning from 3/29/2016 to 10/9/2025.
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. Medreich Limited's FEI number is 3006448684.
What types of violations has Medreich Limited received?
Medreich Limited has been cited for 2 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 Medreich Limited come from?
All FDA import refusal data for Medreich 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.