Laboratorio Sanderson S.A.
⚠️ High Risk
FEI: 3002890029 • Santiago • CHILE
FEI Number
3002890029
Location
Santiago
Country
CHILEAddress
Carlos Fernandez 244, Comuna San Joaquin, Santiago, , Chile
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2024 | 65RAF18SODIUM BICARBONATE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 60CCP04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60QCP03KETAMINE HCL (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61KCP05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60CCP04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60CCP04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 65FCP03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 65LDO06CALAMINE (PROTECTANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/20/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/2/2010 | 61KCP05ATROPINE SULFATE (ANTI-CHOLINERGIC) | New York District Office (NYK-DO) | |
| 6/2/2010 | 60CCP04EPINEPHRINE (ADRENERGIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratorio Sanderson S.A.'s FDA import refusal history?
Laboratorio Sanderson S.A. (FEI: 3002890029) has 12 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 4/21/2024.
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. Laboratorio Sanderson S.A.'s FEI number is 3002890029.
What types of violations has Laboratorio Sanderson S.A. received?
Laboratorio Sanderson S.A. 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 Laboratorio Sanderson S.A. come from?
All FDA import refusal data for Laboratorio Sanderson 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.