Summary
High-impact items this period
El Gordo Spices, LLC
Seafood products prepared in insanitary conditions
Why: HACCP and CGMP violations causing food adulteration ·
Sep 30 ·
Impact: HIGH
Tobacco Paradise LLC
Tobacco products adulterated and misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Sep 30 ·
Impact: HIGH
MicroVention Costa Rica S.R.L.
Adulterated medical device CGMP/QSR violations
Why: Non-compliance with device manufacturing and quality standards ·
Sep 30 ·
Impact: HIGH
Lite-Up Anywhere Ltd.
Tobacco control act violations and misbranded products
Why: Marketing tobacco products without required regulatory authorization and approval ·
Sep 29 ·
Impact: HIGH
La Crosse Smokes 4 Less 1 Inc. d/b/a SMOKES 4 LESS
Tobacco control act violations and misbranded products
Why: Selling tobacco products without required regulatory approval and labeling ·
Sep 29 ·
Impact: HIGH
American Legends Eliquid
Tobacco control act violations and misbranded products
Why: Unauthorized marketing of tobacco vaping products without premarket review ·
Sep 29 ·
Impact: HIGH
Bespoke Apothecary LLC
Unapproved COVID-19 products and misbranding
Why: Selling unproven COVID-19 treatments without regulatory approval ·
Sep 28 ·
Impact: HIGH
Sterling Pharmaceutical Services, LLC
CGMP violations and adulterated finished pharmaceuticals
Why: Failure to comply with manufacturing standards for finished drug products ·
Sep 27 ·
Impact: HIGH
Ecig Vapor Juice Store
Tobacco control act violations and misbranded products
Why: Marketing tobacco products without required FDA premarket authorization ·
Sep 27 ·
Impact: HIGH
Lupin Limited
Active pharmaceutical ingredients non-compliant with CGMP
Why: API manufacturing violated Current Good Manufacturing Practice standards ·
Sep 27 ·
Impact: HIGH
Selected medium-impact items
Vero USA Corporation
Failed to implement Foreign Supplier Verification Program
Why: Inadequate supplier verification procedures and documentation controls ·
Sep 26 ·
Impact: MEDIUM
ARYZ Trading LLC
Foreign supplier verification program non-compliance
Why: Failure to adequately verify foreign food suppliers ·
Sep 21 ·
Impact: MEDIUM
Mena Produce LLC
Foreign supplier verification program violations
Why: Inadequate verification procedures for imported food suppliers ·
Sep 20 ·
Impact: MEDIUM
Eco Lips, Inc.
CGMP violations in finished pharmaceutical/cosmetic lip product manufacturing
Why: Manufacturing quality and control procedures deficiencies in product production ·
Sep 20 ·
Impact: MEDIUM
Effingham Equity
CGMP violations in adulterated medicated feeds
Why: Current good manufacturing practice deviations in feed production ·
Sep 20 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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