Heiltropfen
⚠️ Moderate Risk
FEI: 3012098365 • Ptujptuj • SLOVENIA
FEI Number
3012098365
Location
Ptujptuj
Country
SLOVENIAAddress
Anastazija Sabina Stanovnik, , Ptujptuj, , Slovenia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/8/2023 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2016 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2016 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/6/2016 | 62GCL82DIMETHYL SULFOXIDE (ANTI-INFLAMMATORY) | Philadelphia District Office (PHI-DO) | |
| 4/6/2016 | 62FCK20IODINE (ANTI-INFECTIVE, TOPICAL) | 473LABELING | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Heiltropfen's FDA import refusal history?
Heiltropfen (FEI: 3012098365) has 5 FDA import refusal record(s) in our database, spanning from 4/6/2016 to 6/8/2023.
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. Heiltropfen's FEI number is 3012098365.
What types of violations has Heiltropfen received?
Heiltropfen 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 Heiltropfen come from?
All FDA import refusal data for Heiltropfen 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.