Laboratorios Recalcine S.A.
⚠️ Moderate Risk
FEI: 3005621220 • Santiago • CHILE
FEI Number
3005621220
Location
Santiago
Country
CHILEAddress
Avda. Pedro De Valdivia 295 Piso, , Santiago, , Chile
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2021 | 63ECA28PROPAFENONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2015 | 65JDB39DROSPIRENONE | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/10/2009 | 62ODA40LISINOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laboratorios Recalcine S.A.'s FDA import refusal history?
Laboratorios Recalcine S.A. (FEI: 3005621220) has 4 FDA import refusal record(s) in our database, spanning from 12/10/2009 to 11/12/2021.
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. Laboratorios Recalcine S.A.'s FEI number is 3005621220.
What types of violations has Laboratorios Recalcine S.A. received?
Laboratorios Recalcine S.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 Laboratorios Recalcine S.A. come from?
All FDA import refusal data for Laboratorios Recalcine S.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.