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Salter Labs de Mexico de S.A. de C.V.

⚠️ Moderate Risk

FEI: 3010272829 • Juarez, Chihuahua • MEXICO

FEI

FEI Number

3010272829

📍

Location

Juarez, Chihuahua

🇲🇽

Country

MEXICO
🏢

Address

Blvd. Independencia #2167, Parque Ind. Las Americas - Horizonte Sur. Cd. Juarez, Juarez, Chihuahua, Mexico

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/19/2011
Latest Refusal
4/19/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
4/19/2011
73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
508NO 510(K)
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Salter Labs de Mexico de S.A. de C.V.'s FDA import refusal history?

Salter Labs de Mexico de S.A. de C.V. (FEI: 3010272829) has 1 FDA import refusal record(s) in our database, spanning from 4/19/2011 to 4/19/2011.

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. Salter Labs de Mexico de S.A. de C.V.'s FEI number is 3010272829.

What types of violations has Salter Labs de Mexico de S.A. de C.V. received?

Salter Labs de Mexico de S.A. de C.V. has been cited for 1 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 Salter Labs de Mexico de S.A. de C.V. come from?

All FDA import refusal data for Salter Labs de Mexico de 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.