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Mission Pharmacal Co

⚠️ Moderate Risk

FEI: 1611748 • San Antonio, TX • UNITED STATES

FEI

FEI Number

1611748

📍

Location

San Antonio, TX

🇺🇸
🏢

Address

1325 E Cesar E Chavez Blvd, , San Antonio, TX, United States

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/23/2023
Latest Refusal
7/5/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
33.9×20%
Frequency
1.8×10%
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

753×

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
6/23/2023
61QCA04TIOPRONIN (ANTI-DIURETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/17/2019
60ICA01POTASSIUM CITRATE (ALKALIZER)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/5/2006
62LCB09TINIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mission Pharmacal Co's FDA import refusal history?

Mission Pharmacal Co (FEI: 1611748) has 3 FDA import refusal record(s) in our database, spanning from 7/5/2006 to 6/23/2023.

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. Mission Pharmacal Co's FEI number is 1611748.

What types of violations has Mission Pharmacal Co received?

Mission Pharmacal Co 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 Mission Pharmacal Co come from?

All FDA import refusal data for Mission Pharmacal Co 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.