Summary
High-impact items this period
Africana Market LLC
Foreign supplier verification program non-compliance
Why: Inadequate foreign supplier verification procedures for imported products ·
Apr 29 ·
Impact: HIGH
Martinez Produce & Seafood Inc
Operating seafood facility under insanitary conditions, food adulteration
Why: Failure to implement HACCP procedures and maintain proper sanitation standards ·
Apr 28 ·
Impact: HIGH
Professional World Store
Device premarket approval violation, misbranded product
Why: Marketing device without required premarket approval clearance ·
Apr 27 ·
Impact: HIGH
BMHshop
Adulterated and misbranded COVID-19 related products
Why: Selling unauthorized coronavirus disease prevention products without FDA approval ·
Apr 26 ·
Impact: HIGH
C&G Laboratorios SA de CV
Manufacturing misbranded unapproved finished pharmaceutical drugs
Why: Distributing pharmaceutical products without FDA approval and improper labeling ·
Apr 26 ·
Impact: HIGH
North American Hirudin Biotech Products Inc.
Marketing misbranded unapproved new drug products
Why: Selling biological products as drugs without FDA approval or proper labeling ·
Apr 21 ·
Impact: HIGH
Proper Nutrition Inc.
New drug products misbranded without FDA approval or labeling
Why: Marketing products as drugs without NDA approval and proper drug labeling ·
Apr 20 ·
Impact: HIGH
K & K Distribution, Inc.
Foreign supplier verification program compliance failure
Why: Inadequate procedures to verify foreign supplier food safety practices ·
Apr 15 ·
Impact: HIGH
pharmacygeoff.md
Unapproved new drug product distribution and misbranding
Why: Selling pharmaceuticals without FDA approval or proper labeling ·
Apr 15 ·
Impact: HIGH
Joe Wise Pharmacy, Inc., dba Wise Pharmacy
Compounding pharmacy adulterated drug product violations
Why: Manufacturing and distributing contaminated or substandard compounded drugs ·
Apr 15 ·
Impact: HIGH
Selected medium-impact items
J & L USA Inc.
Failing Foreign Supplier Verification Program requirements
Why: Inadequate verification procedures for imported food products from foreign suppliers ·
Apr 30 ·
Impact: MEDIUM
Wismettac Asian Foods, Inc.
Failing Foreign Supplier Verification Program compliance requirements
Why: Inadequate verification and monitoring of foreign food suppliers and products ·
Apr 29 ·
Impact: MEDIUM
Crown Wellness, Inc
Marketing misbranded unapproved new drug products
Why: Selling products as drugs without FDA approval or proper drug labeling ·
Apr 29 ·
Impact: MEDIUM
NeuroHydrate LLC
Marketing misbranded products as unapproved new drugs
Why: Making drug claims without FDA approval for product formulation ·
Apr 27 ·
Impact: MEDIUM
Smokecignals LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Apr 23 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →