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FDA Enforcement — December 2022 Report

Automated analysis of 37 items from public government data sources. Updated daily.

Summary

37
Total items
28
High impact
9
Medium impact
0
Low impact

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 →