Summary
High-impact items this period
GuangZhou YouXing Cosmetic Co., Ltd
Unapproved pharmaceutical with CGMP violations
Why: Manufacturing and distributing unapproved drugs without proper quality controls ·
Sep 30 ·
Impact: HIGH
Marcus Research Laboratory, Inc.
Active pharmaceutical ingredient adulteration
Why: CGMP violations in API manufacturing process ·
Sep 30 ·
Impact: HIGH
Missouri Analytical Laboratories Inc
Active pharmaceutical ingredient adulteration
Why: CGMP violations in API manufacturing process ·
Sep 30 ·
Impact: HIGH
RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.
Institutional review board compliance failure
Why: Inadequate IRB oversight of bioresearch activities ·
Sep 30 ·
Impact: HIGH
Limpo Quimicos, SA de CV
CGMP violations, unapproved drug, misbranded, adulterated
Why: Manufacturing deficiencies and unauthorized distribution of pharmaceuticals ·
Sep 30 ·
Impact: HIGH
HealthMEDS Inc.
Failure to permit FDA access to records
Why: Obstructed FDA inspection or record access rights ·
Sep 29 ·
Impact: HIGH
Healthy Foods & Nutrition Lab de Mexico S.A. de C.V.
Unapproved new drug products marketed with misbranded claims
Why: Distribution of unapproved pharmaceutical products without regulatory approval ·
Sep 29 ·
Impact: HIGH
Strategia Project Management, Inc.
Unapproved COVID-19 drug product distribution
Why: Selling unapproved coronavirus treatment products ·
Sep 28 ·
Impact: HIGH
Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation
Pharmaceutical CGMP violation with adulterated finished product
Why: Manufacturing practice deviations in finished pharmaceutical preparation ·
Sep 24 ·
Impact: HIGH
Supplement Science Corp. d/b/a Condemned Labz
Unapproved new drug products marketed with misbranded claims
Why: Selling supplements marketed as unapproved drugs without proper authorization ·
Sep 22 ·
Impact: HIGH
Selected medium-impact items
True Chemical Solutions, LLC
Failure to permit FDA access to records and data
Why: Non-compliance with regulatory record inspection and copying requirements ·
Sep 29 ·
Impact: MEDIUM
Kings of Vapor
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Sep 27 ·
Impact: MEDIUM
The Camel Milk Co. LLC dba Camel Culture
Misbranded product marketed as new drug
Why: Making therapeutic claims without approval as drug product ·
Sep 22 ·
Impact: MEDIUM
Dulces La Mejor, LLC
Foreign supplier verification program violations for food imports
Why: Inadequate foreign supplier verification and food safety procedures ·
Sep 15 ·
Impact: MEDIUM
Selected Food & Beverage, Inc.
Foreign supplier verification program non-compliance
Why: Inadequate verification procedures for foreign food suppliers ·
Sep 07 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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