Wockhardt Limited
⚠️ Moderate Risk
FEI: 3005289335 • Aurangabad, Maharashtra • INDIA
FEI Number
3005289335
Location
Aurangabad, Maharashtra
Country
INDIAAddress
H - 14/2 Midc Area, Waluj, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2022 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 10/19/2022 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 10/19/2022 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Wockhardt Limited's FDA import refusal history?
Wockhardt Limited (FEI: 3005289335) has 3 FDA import refusal record(s) in our database, spanning from 10/19/2022 to 10/19/2022.
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 3005289335.
What types of violations has Wockhardt Limited received?
Wockhardt Limited has been cited for 1 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.