Summary
High-impact items this period
Acrostak Schweiz AG
CGMP violations in medical device manufacturing
Why: Non-compliance with current good manufacturing practice standards ·
Oct 31 ·
Impact: HIGH
Dexterity Health, LLC DBA Zazzee Naturals
Unapproved new drug marketed without FDA approval
Why: Pharmaceutical product marketed as drug without premarket FDA approval ·
Oct 30 ·
Impact: HIGH
Neurotris, Inc. dba A1 Engineering
Medical device lacks PMA/510(k), adulterated and misbranded
Why: Distributing medical devices without required premarket approval or clearance ·
Oct 27 ·
Impact: HIGH
Brenntag Great Lakes, LLC
CGMP violations in finished pharmaceutical manufacturing
Why: Non-compliance with current Good Manufacturing Practice standards ·
Oct 26 ·
Impact: HIGH
Abbott Laboratories
Dietary supplement adulteration violation
Why: Manufacturing or distribution of adulterated dietary supplement products ·
Oct 24 ·
Impact: HIGH
Elemental Herbs Inc. d/b/a ALL good
Adulterated finished pharmaceutical products CGMP violations
Why: Failure to maintain CGMP standards in production facility ·
Oct 20 ·
Impact: HIGH
WAVi Co.
Adulterated medical device in IDE/PMA application
Why: Medical device fails to meet quality standards under investigational or approval process ·
Oct 20 ·
Impact: HIGH
Samm Solutions, Inc., d.b.a. BTS Research
Good laboratory practice violations in nonclinical studies
Why: Laboratory fails to meet GLP standards for nonclinical safety testing ·
Oct 20 ·
Impact: HIGH
Maria W. Greenwald, M.D.
Clinical investigator protocol violations in drug trials
Why: Principal investigator fails to comply with clinical investigation regulations ·
Oct 20 ·
Impact: HIGH
Global Pharma Healthcare Private Limited
Pharmaceutical adulteration and misbranding CGMP violations
Why: Failure to comply with pharmaceutical manufacturing standards ·
Oct 20 ·
Impact: HIGH
Selected medium-impact items
Trippy Drips LLC
Tobacco product adulterated or misbranded under FPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Oct 26 ·
Impact: MEDIUM
FF Vapors, LLC
Tobacco product adulterated or misbranded under FPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Oct 26 ·
Impact: MEDIUM
Cajun Vapes LLC
Tobacco product adulterated or misbranded under FPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Oct 26 ·
Impact: MEDIUM
ADM Animal Nutrition
Animal food adulteration and CGMP violations
Why: Failure to maintain Current Good Manufacturing Practice standards ·
Oct 23 ·
Impact: MEDIUM
The Juice Bar
Adulterated or misbranded tobacco products violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Oct 20 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →