Wockhardt Limited
⚠️ Moderate Risk
FEI: 3002808503 • Aurangabad, Maharashtra • INDIA
FEI Number
3002808503
Location
Aurangabad, Maharashtra
Country
INDIAAddress
L-1, MIDC Area, Jalgaon Road 43, Chikalthana, Aurangabad, 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
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).
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/5/2016 | 66YAA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Chicago District Office (CHI-DO) | |
| 2/5/2016 | 66YAA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Chicago District Office (CHI-DO) | |
| 10/22/2014 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 10/22/2014 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 10/22/2014 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 10/20/2014 | 61NCB80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Chicago District Office (CHI-DO) |
| 10/20/2014 | 61NCB80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Chicago District Office (CHI-DO) |
| 10/20/2014 | 61NCB80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Chicago District Office (CHI-DO) |
| 5/19/2005 | 61XIS45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wockhardt Limited's FDA import refusal history?
Wockhardt Limited (FEI: 3002808503) has 9 FDA import refusal record(s) in our database, spanning from 5/19/2005 to 2/5/2016.
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. Wockhardt Limited's FEI number is 3002808503.
What types of violations has Wockhardt Limited received?
Wockhardt Limited has been cited for 5 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 Wockhardt Limited come from?
All FDA import refusal data for Wockhardt 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.