Wockhardt, Ltd.
⚠️ Moderate Risk
FEI: 3002808500 • Ankleshwar, Gujarat • INDIA
FEI Number
3002808500
Location
Ankleshwar, Gujarat
Country
INDIAAddress
Sf-12 Shrinathji Arcade Plot 138, Bulk Drug Division; Karmatur Road, Ankleshwar, Gujarat, 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 11/9/2017 | 56YCR99ANTIBIOTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/9/2017 | 56YCR99ANTIBIOTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/9/2017 | 56YCR99ANTIBIOTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/13/2011 | 60LIY99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Wockhardt, Ltd.'s FDA import refusal history?
Wockhardt, Ltd. (FEI: 3002808500) has 4 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 11/9/2017.
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 3002808500.
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.