ACME Formulation Private Limited
⚠️ High Risk
FEI: 3016859498 • Solan, Himachal Pradesh • INDIA
FEI Number
3016859498
Location
Solan, Himachal Pradesh
Country
INDIAAddress
Hormone Block, Village Ghogharwal (Chokiwala), Ropar Road, Nalagarh, Solan, Himachal Pradesh, 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 |
|---|---|---|---|
| 9/23/2025 | 62KDE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2024 | 62TDB06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2012 | 61NDA23DOTHIEPIN HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/9/2012 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/30/2012 | 64FAY24BROMOCRIPTINE MESYLATE (ENZYME INHIBITOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/8/2010 | 65VCA56ZOLPIDEM TARTRATE (SEDATIVE) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is ACME Formulation Private Limited's FDA import refusal history?
ACME Formulation Private Limited (FEI: 3016859498) has 6 FDA import refusal record(s) in our database, spanning from 3/8/2010 to 9/23/2025.
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. ACME Formulation Private Limited's FEI number is 3016859498.
What types of violations has ACME Formulation Private Limited received?
ACME Formulation Private Limited 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 ACME Formulation Private Limited come from?
All FDA import refusal data for ACME Formulation Private Limited 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.