PAWAN KUMAR
⚠️ High Risk
FEI: 3017058078 • New Delhi, Delhi • INDIA
FEI Number
3017058078
Location
New Delhi, Delhi
Country
INDIAAddress
B 31/43 Guru Ram Dass, Jalandhar, New Delhi, Delhi, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2020 | 65RDY05CALCIUM LACTATE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 61XDY51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 62UDY13HYDROCODONE BITARTRATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 56IDY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 62LDY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 54AGY16VITAMIN E (TOCOPHEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 54AGY12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 62VDY45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 61ADY06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 54AGY99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PAWAN KUMAR's FDA import refusal history?
PAWAN KUMAR (FEI: 3017058078) has 13 FDA import refusal record(s) in our database, spanning from 7/21/2020 to 7/21/2020.
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. PAWAN KUMAR's FEI number is 3017058078.
What types of violations has PAWAN KUMAR received?
PAWAN KUMAR 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 PAWAN KUMAR come from?
All FDA import refusal data for PAWAN KUMAR 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.