South India Research Institute Pvt. Ltd
⚠️ High Risk
FEI: 3009470985 • Vijayawada, Andhra Pradesh • INDIA
FEI Number
3009470985
Location
Vijayawada, Andhra Pradesh
Country
INDIAAddress
Sirinagar, , Vijayawada, Andhra 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2025 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/30/2025 | 60VCL99ANTERIOR PITUITARY SUPPRESSOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/3/2025 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/17/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/16/2024 | 60SBL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2023 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/13/2019 | 60SCL99ANTACID, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/26/2017 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 1/19/2016 | 66VCT99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 9/9/2014 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/4/2013 | 60SBL99ANTACID, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 60SBL99ANTACID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/26/2012 | 54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is South India Research Institute Pvt. Ltd's FDA import refusal history?
South India Research Institute Pvt. Ltd (FEI: 3009470985) has 28 FDA import refusal record(s) in our database, spanning from 6/26/2012 to 7/29/2025.
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. South India Research Institute Pvt. Ltd's FEI number is 3009470985.
What types of violations has South India Research Institute Pvt. Ltd received?
South India Research Institute Pvt. Ltd has been cited for 6 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 South India Research Institute Pvt. Ltd come from?
All FDA import refusal data for South India Research Institute Pvt. 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.