W. WOODWARD PAKISTAN LTD.
⚠️ Moderate Risk
FEI: 3002817109 • KARACHI • PAKISTAN
FEI Number
3002817109
Location
KARACHI
Country
PAKISTANAddress
F-275, S.I.T.E.,, , KARACHI, , Pakistan
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
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2019 | 65RBL18SODIUM BICARBONATE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/15/2012 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/17/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is W. WOODWARD PAKISTAN LTD.'s FDA import refusal history?
W. WOODWARD PAKISTAN LTD. (FEI: 3002817109) has 3 FDA import refusal record(s) in our database, spanning from 4/17/2008 to 4/2/2019.
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. W. WOODWARD PAKISTAN LTD.'s FEI number is 3002817109.
What types of violations has W. WOODWARD PAKISTAN LTD. received?
W. WOODWARD PAKISTAN LTD. has been cited for 2 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 W. WOODWARD PAKISTAN LTD. come from?
All FDA import refusal data for W. WOODWARD PAKISTAN 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.