Balkanpharma-Troyan AD
⚠️ Moderate Risk
FEI: 3008616485 • Troyan, oblast Lovech • BULGARIA
FEI Number
3008616485
Location
Troyan, oblast Lovech
Country
BULGARIAAddress
Krayrechna Str. 1, , Troyan, oblast Lovech, Bulgaria
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2023 | 65LBO15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 5/9/2012 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 1/12/2012 | 66VDO99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 6/28/2011 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Balkanpharma-Troyan AD's FDA import refusal history?
Balkanpharma-Troyan AD (FEI: 3008616485) has 4 FDA import refusal record(s) in our database, spanning from 6/28/2011 to 12/1/2023.
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. Balkanpharma-Troyan AD's FEI number is 3008616485.
What types of violations has Balkanpharma-Troyan AD received?
Balkanpharma-Troyan AD has been cited for 8 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 Balkanpharma-Troyan AD come from?
All FDA import refusal data for Balkanpharma-Troyan AD 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.