Wockhardt Ltd.
⚠️ High Risk
FEI: 3004272092 • Mumbai, Maharashtra • INDIA
FEI Number
3004272092
Location
Mumbai, Maharashtra
Country
INDIAAddress
West Wing, 8 Wockhardt Tower; Level, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2025 | 54AGK10MECOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/28/2025 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2025 | 54AFY10MECOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2024 | 56ODY02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 61XDA51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2011 | 62CCB65LISINOPRIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 4/17/2008 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/25/2008 | 62UCS11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 2/27/2006 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 2/27/2006 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 9/8/2004 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/18/2004 | 62OIR20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/28/2004 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/28/2004 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/25/2004 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/25/2004 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/25/2004 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/25/2004 | 65PDA99REGULATOR N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wockhardt Ltd.'s FDA import refusal history?
Wockhardt Ltd. (FEI: 3004272092) has 18 FDA import refusal record(s) in our database, spanning from 3/25/2004 to 10/21/2025.
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. Wockhardt Ltd.'s FEI number is 3004272092.
What types of violations has Wockhardt Ltd. received?
Wockhardt Ltd. has been cited for 3 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 Ltd. come from?
All FDA import refusal data for Wockhardt 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.