Shalina Laboratories Limited
⚠️ High Risk
FEI: 3003705104 • Mumbai, Maharashtra • INDIA
FEI Number
3003705104
Location
Mumbai, Maharashtra
Country
INDIAAddress
96 Maker Chamber V, , Mumbai, Maharashtra, 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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
ADDDRUGBIO
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2024 | 62GDA41IBUPROFEN (ANTI-INFLAMMATORY) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 10/7/2024 | 61ABJ11IODOCHLORHYDROXYQUIN (ANTI-AMEBIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/23/2024 | 56DBJ21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/20/2024 | 62GRA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/19/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) | |
| 6/27/2024 | 61WDY31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/3/2024 | 64LBO06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/30/2021 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 10/22/2021 | 61XBB14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 4/20/2020 | 54ACS02VITAMIN B1 (THIAMINE) | 3887ADDDRUGBIO | Division of Northeast Imports (DNEI) |
| 9/7/2017 | 64LCJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 9/4/2017 | 64LDO06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 11/4/2016 | 62LCE09TINIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/6/2015 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Baltimore District Office (BLT-DO) | |
| 9/4/2014 | 64LBJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 12/9/2011 | 63VDJ02HYDROQUINONE (DEPIGMENTOR) | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 3/22/2006 | 64LCJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shalina Laboratories Limited's FDA import refusal history?
Shalina Laboratories Limited (FEI: 3003705104) has 18 FDA import refusal record(s) in our database, spanning from 3/22/2006 to 11/22/2024.
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. Shalina Laboratories Limited's FEI number is 3003705104.
What types of violations has Shalina Laboratories Limited received?
Shalina Laboratories Limited has been cited for 12 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 Shalina Laboratories Limited come from?
All FDA import refusal data for Shalina Laboratories 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.