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SHAWI RSHEDAT MASANAT DRUG STORE

⚠️ Moderate Risk

FEI: 3021979809 • Gaithersburg, MD • UNITED STATES

FEI

FEI Number

3021979809

📍

Location

Gaithersburg, MD

🇺🇸
🏢

Address

Novavax, 21 Firstfield Rd, Gaithersburg, MD, United States

Moderate Risk

FDA Import Risk Assessment

42.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/27/2022
Latest Refusal
4/27/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
11.8×20%
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

751×

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
4/27/2022
62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHAWI RSHEDAT MASANAT DRUG STORE's FDA import refusal history?

SHAWI RSHEDAT MASANAT DRUG STORE (FEI: 3021979809) has 1 FDA import refusal record(s) in our database, spanning from 4/27/2022 to 4/27/2022.

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. SHAWI RSHEDAT MASANAT DRUG STORE's FEI number is 3021979809.

What types of violations has SHAWI RSHEDAT MASANAT DRUG STORE received?

SHAWI RSHEDAT MASANAT DRUG STORE 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 SHAWI RSHEDAT MASANAT DRUG STORE come from?

All FDA import refusal data for SHAWI RSHEDAT MASANAT DRUG STORE 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.