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Celestica Monterrey SA de CV

⚠️ Moderate Risk

FEI: 3003139373 • Apodaca, Nuevo Leon • MEXICO

FEI

FEI Number

3003139373

📍

Location

Apodaca, Nuevo Leon

🇲🇽

Country

MEXICO
🏢

Address

Calle Octava #102 Parque Ind. Moterrey, , Apodaca, Nuevo Leon, Mexico

Moderate Risk

FDA Import Risk Assessment

27.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/3/2022
Latest Refusal
6/3/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
13.8×20%
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

1181×

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

DateProductViolationsDivision
6/3/2022
78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Celestica Monterrey SA de CV's FDA import refusal history?

Celestica Monterrey SA de CV (FEI: 3003139373) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2022 to 6/3/2022.

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. Celestica Monterrey SA de CV's FEI number is 3003139373.

What types of violations has Celestica Monterrey SA de CV received?

Celestica Monterrey SA de CV 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 Celestica Monterrey SA de CV come from?

All FDA import refusal data for Celestica Monterrey SA de CV 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.