LABORATORIOS SUIZOS S.A. DE C.V.
⚠️ High Risk
FEI: 3010200377 • Antiguo Cuscatlan, La Libertad • EL SALVADOR
FEI Number
3010200377
Location
Antiguo Cuscatlan, La Libertad
Country
EL SALVADORAddress
Km 10 Carretera al Puerto de La Libertad, , Antiguo Cuscatlan, La Libertad, El Salvador
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 1/21/2026 | 54AGA99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/5/2022 | 62TCH06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 56ICE76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2009 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 472NO ENGLISH | Atlanta District Office (ATL-DO) |
| 11/5/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 472NO ENGLISH | Atlanta District Office (ATL-DO) |
| 11/5/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 472NO ENGLISH | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is LABORATORIOS SUIZOS S.A. DE C.V.'s FDA import refusal history?
LABORATORIOS SUIZOS S.A. DE C.V. (FEI: 3010200377) has 6 FDA import refusal record(s) in our database, spanning from 11/5/2009 to 1/21/2026.
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 SUIZOS S.A. DE C.V.'s FEI number is 3010200377.
What types of violations has LABORATORIOS SUIZOS S.A. DE C.V. received?
LABORATORIOS SUIZOS S.A. DE C.V. has been cited for 3 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 SUIZOS S.A. DE C.V. come from?
All FDA import refusal data for LABORATORIOS SUIZOS S.A. DE C.V. 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.