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LABORATORIOS PISA SA DE CV

⚠️ High Risk

FEI: 3019763759 • Iztacalco, MEX • MEXICO

FEI

FEI Number

3019763759

📍

Location

Iztacalco, MEX

🇲🇽

Country

MEXICO
🏢

Address

Avenida Nte 220 Agricol, , Iztacalco, MEX, Mexico

High Risk

FDA Import Risk Assessment

58.4
LowModerateHighCritical

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

Statistics

8
Total Refusals
1
Unique Violations
9/13/2022
Latest Refusal
9/13/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
35.3×30%
Recency
19.1×20%
Frequency
80.0×10%
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

758×

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

DateProductViolationsDivision
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/13/2022
29CHT99NONALCOHOLIC BEVERAGES, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is LABORATORIOS PISA SA DE CV's FDA import refusal history?

LABORATORIOS PISA SA DE CV (FEI: 3019763759) has 8 FDA import refusal record(s) in our database, spanning from 9/13/2022 to 9/13/2022.

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. LABORATORIOS PISA SA DE CV's FEI number is 3019763759.

What types of violations has LABORATORIOS PISA SA DE CV received?

LABORATORIOS PISA 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 LABORATORIOS PISA SA DE CV come from?

All FDA import refusal data for LABORATORIOS PISA 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.