Halka Industrial SRL
⚠️ Moderate Risk
FEI: 3005425979 • Santo Domingo Este, Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3005425979
Location
Santo Domingo Este, Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle Juan Luis Duquela # 2, , Santo Domingo Este, Santo Domingo, Dominican Republic
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2013 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/3/2013 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/2/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Halka Industrial SRL's FDA import refusal history?
Halka Industrial SRL (FEI: 3005425979) has 3 FDA import refusal record(s) in our database, spanning from 4/2/2010 to 4/3/2013.
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. Halka Industrial SRL's FEI number is 3005425979.
What types of violations has Halka Industrial SRL received?
Halka Industrial SRL 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 Halka Industrial SRL come from?
All FDA import refusal data for Halka Industrial SRL 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.