TABLETS (INDIA) LIMITED
⚠️ Moderate Risk
FEI: 3001683687 • Madras • INDIA
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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.
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).
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).
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2014 | 61XCY14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/27/2014 | 61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 8/27/2014 | 61XDL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 6/6/2014 | 61XBN14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 1/13/2014 | 61XDN14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 5/28/2013 | 61XDN14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 2/16/2010 | 61XDL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | New England District Office (NWE-DO) | |
| 1/17/2007 | 61XDL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 5/4/2004 | 61XPL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/22/2003 | 61XDL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TABLETS (INDIA) LIMITED's FDA import refusal history?
TABLETS (INDIA) LIMITED (FEI: 3001683687) has 11 FDA import refusal record(s) in our database, spanning from 8/22/2003 to 12/23/2014.
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. TABLETS (INDIA) LIMITED's FEI number is 3001683687.
What types of violations has TABLETS (INDIA) LIMITED received?
TABLETS (INDIA) LIMITED has been cited for 8 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 TABLETS (INDIA) LIMITED come from?
All FDA import refusal data for TABLETS (INDIA) 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.