Prakash Airfreight P Ltd
⚠️ High Risk
FEI: 3004524381 • Mumbai, Maharashtra • INDIA
FEI Number
3004524381
Location
Mumbai, Maharashtra
Country
INDIAAddress
A - 9 Tushar Park, Tipu Sultan Road, Mumbai, Maharashtra, 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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2004 | 63XCB99DIAGOSTIC AID (DRUGS) N.E.C. | New Orleans District Office (NOL-DO) | |
| 5/28/2004 | 61FDB55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 61TDY28ONDANSETRON HYDROCHLORIDE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 62VDY08IDOXURIDINE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 66VCF99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 65VCY15DIAZEPAM (SEDATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Prakash Airfreight P Ltd's FDA import refusal history?
Prakash Airfreight P Ltd (FEI: 3004524381) has 9 FDA import refusal record(s) in our database, spanning from 5/28/2004 to 10/13/2004.
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. Prakash Airfreight P Ltd's FEI number is 3004524381.
What types of violations has Prakash Airfreight P Ltd received?
Prakash Airfreight P Ltd has been cited for 4 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 Prakash Airfreight P Ltd come from?
All FDA import refusal data for Prakash Airfreight P 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.