AINSA S.A. DE C.V.
⚠️ Moderate Risk
FEI: 3010695112 • San Salvador, San Salvador • EL SALVADOR
FEI Number
3010695112
Location
San Salvador, San Salvador
Country
EL SALVADORAddress
49 Av. sur Colonia Harrison Pasaje 1 #, 16, San Salvador, San Salvador, El Salvador
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/21/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Los Angeles District Office (LOS-DO) | |
| 12/21/2011 | 62FBL99ANTI-INFECTIVE, TOPICAL N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/21/2011 | 56GYL99ANTIFUNGAL N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is AINSA S.A. DE C.V.'s FDA import refusal history?
AINSA S.A. DE C.V. (FEI: 3010695112) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2011 to 12/21/2011.
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. AINSA S.A. DE C.V.'s FEI number is 3010695112.
What types of violations has AINSA S.A. DE C.V. received?
AINSA S.A. DE C.V. 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 AINSA S.A. DE C.V. come from?
All FDA import refusal data for AINSA 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.