MR PANKAJ P SHEWALE
⚠️ High Risk
FEI: 3017138831 • Nasik Budwar Peth • INDIA
FEI Number
3017138831
Location
Nasik Budwar Peth
Country
INDIAAddress
Sham Villa Row House No. 5, , Nasik Budwar Peth, , 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 |
|---|---|---|---|
| 8/19/2020 | 64TDA99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 60QDL56BENZOCAINE (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 55QY27ANHYDROUS LANOLIN (PHARMACEUTIC NECESSITY - ABSORBENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 54FGA94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 61WDJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 60SCA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 62GCA48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 61XDA51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MR PANKAJ P SHEWALE's FDA import refusal history?
MR PANKAJ P SHEWALE (FEI: 3017138831) has 12 FDA import refusal record(s) in our database, spanning from 8/19/2020 to 8/19/2020.
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. MR PANKAJ P SHEWALE's FEI number is 3017138831.
What types of violations has MR PANKAJ P SHEWALE received?
MR PANKAJ P SHEWALE 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 MR PANKAJ P SHEWALE come from?
All FDA import refusal data for MR PANKAJ P SHEWALE 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.