MMC HEALTHCARE LTD.
⚠️ High Risk
FEI: 3014773352 • Chennai, Tamil Nadu • INDIA
FEI Number
3014773352
Location
Chennai, Tamil Nadu
Country
INDIAAddress
34-B Sidco Industrial Estate, Thirumazhisai, Chennai, Tamil Nadu, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 1/29/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/21/2024 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/23/2024 | 54AEA99VITAMIN, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/16/2024 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 7/21/2022 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MMC HEALTHCARE LTD.'s FDA import refusal history?
MMC HEALTHCARE LTD. (FEI: 3014773352) has 5 FDA import refusal record(s) in our database, spanning from 7/21/2022 to 1/29/2025.
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. MMC HEALTHCARE LTD.'s FEI number is 3014773352.
What types of violations has MMC HEALTHCARE LTD. received?
MMC HEALTHCARE LTD. has been cited for 4 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 MMC HEALTHCARE LTD. come from?
All FDA import refusal data for MMC HEALTHCARE 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.