Summary
High-impact items this period
Salazar & Sons Corp
Failed to implement Foreign Supplier Verification Program
Why: Inadequate foreign supplier verification procedures and documentation ·
Dec 29 ·
Impact: HIGH
Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa
Medical device adulteration and CGMP/QSR violations
Why: Failure to maintain Current Good Manufacturing Practice standards ·
Dec 29 ·
Impact: HIGH
Getsch+Hiller Medizintechnik GmbH
Adulterated medical device CGMP/QSR violations
Why: Non-compliance with device manufacturing and quality standards ·
Dec 27 ·
Impact: HIGH
globalpharmacyplus.com
Unlawful online sale of unapproved misbranded drugs
Why: Distribution of unauthorized pharmaceuticals via internet to consumers ·
Dec 27 ·
Impact: HIGH
North American Diagnostics, LLC
Medical device adulterated, misbranded, lacks PMA and 510(k)
Why: Device marketed without required premarket approval or clearance documentation ·
Dec 27 ·
Impact: HIGH
Urban Electric Power
Adulterated drug products CGMP violations
Why: Current good manufacturing practice violations in drug production ·
Dec 27 ·
Impact: HIGH
JP & SN Enterprises Inc. d/b/a eCigs International
Tobacco products adulterated and misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 22 ·
Impact: HIGH
BS Vapes LLC
Tobacco products adulterated and misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 22 ·
Impact: HIGH
Salon Technologies International, Inc.
Adulterated finished pharmaceutical product CGMP violations
Why: Non-compliance with current Good Manufacturing Practices standards ·
Dec 21 ·
Impact: HIGH
RightEye, LLC
Adulterated medical device IDE/PMA application violations
Why: Device not compliant with investigational or premarket approval requirements ·
Dec 20 ·
Impact: HIGH
Selected medium-impact items
Vape King Inc.
Tobacco product adulterated or misbranded distribution
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 15 ·
Impact: MEDIUM
Vapor E-Cigarette, L.L.C.
Tobacco product adulterated or misbranded distribution
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 15 ·
Impact: MEDIUM
Quality Supplement Manufacturing, Inc.
Adulterated dietary supplement CGMP manufacturing violations
Why: Non-compliance with manufacturing and labeling standards ·
Dec 13 ·
Impact: MEDIUM
Olympus Medical Systems Corporation
Medical device misbranding and reporting violations
Why: Failure to properly report adverse events and labeling defects ·
Dec 12 ·
Impact: MEDIUM
Ruth Special Food Store LLC
Failed to implement Foreign Supplier Verification Program
Why: Inadequate supplier verification and food safety documentation controls ·
Dec 09 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →