ASO Americas, S. de RL de C.V.

⚠️ High Risk

FEI: 3005761322 • Juarez, Chihuahua • MEXICO

FEI

FEI Number

3005761322

📍

Location

Juarez, Chihuahua

🇲🇽

Country

MEXICO

🏢

Address

Rio Michigan No. 9730, Parque Industrial Centro Industrial Juarez, Juarez, Juarez, Chihuahua, Mexico

High Risk

FDA Import Risk Assessment

51.6

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

3/14/2016

Latest Refusal

12/14/2012

Earliest Refusal

Score Breakdown

Violation Severity

75.7×40%

Refusal Volume

49.7×30%

Recency

0.0×20%

Frequency

64.6×10%

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

Violation Summary

47915×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

33803×

EXPIRED

the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.

783×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

20201×

LBLG ADVER

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.

751×

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
3/14/2016	64XAJ06SALICYLIC ACID (KERATOLYTIC)	75UNAPPROVED	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
9/14/2015	79KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY	Southwest Import District Office (SWI-DO)
2/17/2015	79KGXTAPE AND BANDAGE, ADHESIVE	2020LBLG ADVER 78STERILITY	Southwest Import District Office (SWI-DO)
6/3/2014	79KGXTAPE AND BANDAGE, ADHESIVE	3380EXPIRED	Southwest Import District Office (SWI-DO)
6/3/2014	79KGXTAPE AND BANDAGE, ADHESIVE	3380EXPIRED	Southwest Import District Office (SWI-DO)
6/3/2014	79KGXTAPE AND BANDAGE, ADHESIVE	3380EXPIRED	Southwest Import District Office (SWI-DO)
12/28/2013	80KGXTAPE AND BANDAGE, ADHESIVE	479DV QUALITY 78STERILITY	Southwest Import District Office (SWI-DO)
12/14/2012	79KGXTAPE AND BANDAGE, ADHESIVE	78STERILITY	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ASO Americas, S. de RL de C.V.'s FDA import refusal history?

ASO Americas, S. de RL de C.V. (FEI: 3005761322) has 21 FDA import refusal record(s) in our database, spanning from 12/14/2012 to 3/14/2016.

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. ASO Americas, S. de RL de C.V.'s FEI number is 3005761322.

What types of violations has ASO Americas, S. de RL de C.V. received?

ASO Americas, S. de RL de C.V. has been cited for 5 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 ASO Americas, S. de RL de C.V. come from?

All FDA import refusal data for ASO Americas, S. de RL 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.