Barrett Hodgson Pakistan (Pvt.) Ltd.
⚠️ High Risk
FEI: 3004771083 • Karachi • PAKISTAN
FEI Number
3004771083
Location
Karachi
Country
PAKISTANAddress
F-423 S.I.T.E., , Karachi, , Pakistan
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2024 | 65QDY65TIZANIDINE HCL (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Barrett Hodgson Pakistan (Pvt.) Ltd.'s FDA import refusal history?
Barrett Hodgson Pakistan (Pvt.) Ltd. (FEI: 3004771083) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2024 to 6/17/2024.
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. Barrett Hodgson Pakistan (Pvt.) Ltd.'s FEI number is 3004771083.
What types of violations has Barrett Hodgson Pakistan (Pvt.) Ltd. received?
Barrett Hodgson Pakistan (Pvt.) Ltd. 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 Barrett Hodgson Pakistan (Pvt.) Ltd. come from?
All FDA import refusal data for Barrett Hodgson Pakistan (Pvt.) 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.