Aadivighnesh Chem PVT. LTD.
⚠️ Moderate Risk
FEI: 3006005111 • Mumbai, Maharashtra • INDIA
FEI Number
3006005111
Location
Mumbai, Maharashtra
Country
INDIAAddress
Plot No. 503, Architects Plaza, Near Dattapada Subway, Mumbai, Maharashtra, 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
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2015 | 64UCT99INHIBITOR N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 6/25/2014 | 62FAS38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | Southwest Import District Office (SWI-DO) | |
| 4/25/2014 | 56CCT66CEFTAZIDIME (CEPHALOSPORINS) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 6/18/2013 | 62KCT08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New Orleans District Office (NOL-DO) | |
| 9/29/2008 | 56KAS10CHLORAMPHENICOL | New York District Office (NYK-DO) | |
| 9/19/2008 | 61NAS32IMIPRAMINE HCL (ANTI-DEPRESSANT) | New Orleans District Office (NOL-DO) | |
| 8/14/2008 | 56KAS11CHLORAMPHENICOL PALMITATE | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/26/2008 | 61NSS32IMIPRAMINE HCL (ANTI-DEPRESSANT) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 11/13/2007 | 56OIY05ENROFLOXACIN (FLUOROQUINOLONE) | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aadivighnesh Chem PVT. LTD.'s FDA import refusal history?
Aadivighnesh Chem PVT. LTD. (FEI: 3006005111) has 9 FDA import refusal record(s) in our database, spanning from 11/13/2007 to 2/19/2015.
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. Aadivighnesh Chem PVT. LTD.'s FEI number is 3006005111.
What types of violations has Aadivighnesh Chem PVT. LTD. received?
Aadivighnesh Chem PVT. LTD. has been cited for 7 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 Aadivighnesh Chem PVT. LTD. come from?
All FDA import refusal data for Aadivighnesh Chem 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.