BALAJI MORPATTI
⚠️ High Risk
FEI: 3030010584 • Haryana • INDIA
FEI Number
3030010584
Location
Haryana
Country
INDIAAddress
Morpatti Narwana Jing, , Haryana, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2024 | 64HAL99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 61XDL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 66MCA83HYDROXYZINE HCL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 60ZDA15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 62GAC11CICLOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 62LCL52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 64LDJ02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BALAJI MORPATTI's FDA import refusal history?
BALAJI MORPATTI (FEI: 3030010584) has 9 FDA import refusal record(s) in our database, spanning from 1/3/2024 to 1/3/2024.
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. BALAJI MORPATTI's FEI number is 3030010584.
What types of violations has BALAJI MORPATTI received?
BALAJI MORPATTI 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 BALAJI MORPATTI come from?
All FDA import refusal data for BALAJI MORPATTI 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.