Taca International Airlines
⚠️ Moderate Risk
FEI: 3007789391 • LA Palma, Chalatenango • EL SALVADOR
FEI Number
3007789391
Location
LA Palma, Chalatenango
Country
EL SALVADORAddress
Aeropuerto Internacional De El Salvador, , LA Palma, Chalatenango, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2012 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Chicago District Office (CHI-DO) |
| 8/1/2012 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Chicago District Office (CHI-DO) | |
| 8/1/2012 | 62MAJ01CAMPHOR (ANTI-PRURITIC) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 12/16/2010 | 76EFWTOOTHBRUSH, MANUAL | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Taca International Airlines's FDA import refusal history?
Taca International Airlines (FEI: 3007789391) has 4 FDA import refusal record(s) in our database, spanning from 12/16/2010 to 8/1/2012.
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. Taca International Airlines's FEI number is 3007789391.
What types of violations has Taca International Airlines received?
Taca International Airlines has been cited for 4 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 Taca International Airlines come from?
All FDA import refusal data for Taca International Airlines 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.