S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A.
⚠️ Moderate Risk
FEI: 3002518976 • Como, Como • ITALY
FEI Number
3002518976
Location
Como, Como
Country
ITALYAddress
Via San Francesco D'Assisi 5, , Como, Como, Italy
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
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 |
|---|---|---|---|
| 3/12/2010 | 60MCS28NALTREXONE HYDROCHLORIDE (ANALGESIC, NARCOTIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 3/3/2010 | 60MSS28NALTREXONE HYDROCHLORIDE (ANALGESIC, NARCOTIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 12/21/2009 | 60MAS28NALTREXONE HYDROCHLORIDE (ANALGESIC, NARCOTIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A.'s FDA import refusal history?
S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A. (FEI: 3002518976) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2009 to 3/12/2010.
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. S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A.'s FEI number is 3002518976.
What types of violations has S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A. received?
S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A. 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 S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A. come from?
All FDA import refusal data for S.A.L.A.R.S. Societa Azionaria Laboratori Alcaloidi Rifornimenti Sanitari, S.p.A. 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.