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Pha Upj

Low Risk

FEI: 1000609497 • Mex • MEXICO

FEI

FEI Number

1000609497

📍

Location

Mex

🇲🇽

Country

MEXICO
🏢

Address

Box 2962, , Mex, , Mexico

Low Risk

FDA Import Risk Assessment

21.6
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
9/24/2008
Latest Refusal
10/17/2001
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.9×10%
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).

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
9/24/2008
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New Orleans District Office (NOL-DO)
10/17/2001
62GDL99ANTI-INFLAMMATORY N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Pha Upj's FDA import refusal history?

Pha Upj (FEI: 1000609497) has 2 FDA import refusal record(s) in our database, spanning from 10/17/2001 to 9/24/2008.

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. Pha Upj's FEI number is 1000609497.

What types of violations has Pha Upj received?

Pha Upj 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 Pha Upj come from?

All FDA import refusal data for Pha Upj 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.