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Manufactura Integrada Del Pacifico

⚠️ Moderate Risk

FEI: 3003449582 • Tijuana, Baja California • MEXICO

FEI

FEI Number

3003449582

📍

Location

Tijuana, Baja California

🇲🇽

Country

MEXICO
🏢

Address

Prolongacion M. Juarez # 1089-3, Col. Jardin Panteon, Tijuana, Tijuana, Baja California, Mexico

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/16/2006
Latest Refusal
10/16/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

5083×

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
10/16/2006
75DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
118NOT LISTED
508NO 510(K)
Southwest Import District Office (SWI-DO)
10/16/2006
75DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
118NOT LISTED
508NO 510(K)
Southwest Import District Office (SWI-DO)
10/16/2006
75DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
118NOT LISTED
508NO 510(K)
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Manufactura Integrada Del Pacifico's FDA import refusal history?

Manufactura Integrada Del Pacifico (FEI: 3003449582) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 10/16/2006.

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. Manufactura Integrada Del Pacifico's FEI number is 3003449582.

What types of violations has Manufactura Integrada Del Pacifico received?

Manufactura Integrada Del Pacifico 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 Manufactura Integrada Del Pacifico come from?

All FDA import refusal data for Manufactura Integrada Del Pacifico 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.