Summary
High-impact items this period
Granules India Limited
Manufacturing adulterated finished pharmaceutical products
Why: CGMP deviations in finished pharmaceutical manufacturing processes or materials ·
Feb 26 ·
Impact: HIGH
TKTX Numbing Cream USA
Marketing unapproved new drug product as OTC
Why: Selling topical numbing product without FDA approval or proper drug classification ·
Feb 25 ·
Impact: HIGH
TKTX USA
Unapproved new drug misbranded as OTC product
Why: Marketing unapproved pharmaceutical product without FDA approval ·
Feb 25 ·
Impact: HIGH
TKTX Store
Marketing unapproved new drug product as OTC
Why: Selling topical numbing product without FDA approval or proper drug classification ·
Feb 25 ·
Impact: HIGH
TKTX Numb Store
Marketing unapproved new drug product as OTC
Why: Selling topical numbing product without FDA approval or proper drug classification ·
Feb 25 ·
Impact: HIGH
Sperm Bank, Inc. dba Fertility Center of California
HCT/P regulations and CFR deviations for cellular products
Why: Non-compliance with human cells, tissues, cellular products regulations ·
Feb 14 ·
Impact: HIGH
Zenzi Pharmaceutical Industries Pvt. Ltd.
Refused FDA access to records and data copying
Why: Non-compliance with FDA inspection authority and record access requirements ·
Feb 13 ·
Impact: HIGH
Chem-Tech, Ltd.
Finished pharmaceutical product adulteration CGMP violation
Why: Current Good Manufacturing Practice non-compliance in finished drug production ·
Feb 11 ·
Impact: HIGH
ABR Laboratory LLC
Finished pharmaceutical product adulteration CGMP violation
Why: Current Good Manufacturing Practice non-compliance in finished drug production ·
Feb 10 ·
Impact: HIGH
Marshalls Traditional Healthcare CC
Adulterated finished pharmaceutical CGMP violations
Why: Manufacturing process non-compliance in finished drug products ·
Feb 10 ·
Impact: HIGH
Selected medium-impact items
The Vapor Club LLC
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 27 ·
Impact: MEDIUM
Elk River Vapor Shop
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 27 ·
Impact: MEDIUM
Loveli Design, LLC d/b/a Alice in Vapeland
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 21 ·
Impact: MEDIUM
A-Z Tobacco Inc d/b/a A-Z Tobacco and Vapor
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 14 ·
Impact: MEDIUM
Gorilla Vapes of East Brunswick
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 14 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →