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FDA Enforcement — August 2024 Report

Automated analysis of 47 items from public government data sources. Updated daily.

Summary

47
Total items
30
High impact
16
Medium impact
1
Low impact

High-impact items this period

Kyokuyo Global Seafoods Co. LTD.
Adulterated seafood HACCP control system failures
Why: Non-compliance with seafood HACCP and food CGMP standards  ·  Aug 30  ·  Impact: HIGH
Procesadora Marina De La Costa Oriental Del Lago C.A.
Seafood adulterated HACCP and CGMP violations
Why: Failure to implement Seafood HACCP and food manufacturing standards  ·  Aug 30  ·  Impact: HIGH
Root Bioscience Brands, LLC dba Naternal
Unapproved new drugs marketed and misbranded
Why: Marketing drugs without FDA approval or required regulatory authorization  ·  Aug 30  ·  Impact: HIGH
Orean Personal Care Ltd.
Adulterated finished pharmaceuticals with CGMP violations
Why: Non-compliance with current Good Manufacturing Practice requirements  ·  Aug 29  ·  Impact: HIGH
Zydus Lifesciences Limited
Adulterated finished pharmaceuticals; CGMP violations
Why: Manufacturing non-compliance or contamination in pharmaceutical production  ·  Aug 29  ·  Impact: HIGH
Everymarket Inc.
Marketing unapproved new drugs as misbranded products
Why: Selling pharmaceutical products without FDA approval or proper drug classification  ·  Aug 27  ·  Impact: HIGH
MexHealth LLC d/b/a Al Natural E-Shop
Marketing unapproved new drugs as misbranded products
Why: Selling pharmaceutical products without FDA approval or proper drug classification  ·  Aug 27  ·  Impact: HIGH
SoloVital
Marketing unapproved new drugs as misbranded products
Why: Selling pharmaceutical products without FDA approval or proper drug classification  ·  Aug 27  ·  Impact: HIGH
California Veterinary Supply
Unapproved medically important antimicrobials for minor species
Why: Marketing antimicrobial products lacking FDA approval for non-food animals  ·  Aug 22  ·  Impact: HIGH
AnuMed International, LLC
Unapproved new drug adulterated and misbranded
Why: Marketing unapproved pharmaceutical products without FDA authorization  ·  Aug 20  ·  Impact: HIGH

Selected medium-impact items

Favorite Daughter, LLC d/b/a Phoenix Vapor Shop
Adulterated and misbranded tobacco products under FSPTCA
Why: Non-compliant tobacco product marketing and manufacturing practices  ·  Aug 29  ·  Impact: MEDIUM
Vape On LLC d/b/a Imperial Vapor Co.
Adulterated and misbranded tobacco products under FSPTCA
Why: Non-compliant tobacco product marketing and manufacturing practices  ·  Aug 29  ·  Impact: MEDIUM
Good Karma Cigar LLC
Adulterated and misbranded tobacco products under FSPTCA
Why: Non-compliant tobacco product marketing and manufacturing practices  ·  Aug 29  ·  Impact: MEDIUM
Barohup Inc.
Foreign Supplier Verification Program compliance failures
Why: Inadequate supplier verification and safety controls  ·  Aug 28  ·  Impact: MEDIUM
Parallel Direct LLC d/b/a The Magic Mist
Adulterated and misbranded tobacco products under FSPTCA
Why: Non-compliant tobacco product marketing and manufacturing practices  ·  Aug 22  ·  Impact: MEDIUM

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Data sourced from public government APIs. AI analysis via Claude Haiku. Full methodology →