Summary
High-impact items this period
OsteoLife Biomedical I LLC
Human tissue products deviate from regulatory requirements
Why: HCT/P manufacturing deviations from FDA CFR regulations ·
Mar 31 ·
Impact: HIGH
Vi-Jon, LLC
CGMP violations and adulterated finished pharmaceutical products
Why: Manufacturing facility deficiencies resulting in product adulteration ·
Mar 31 ·
Impact: HIGH
Vapor Vapes Inc.
Tobacco products misbranded and adulterated violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Mar 30 ·
Impact: HIGH
kubapharm.com
Unlawful Schedule II stimulant sales over internet
Why: Controlled substances sold directly to consumers without proper licensing ·
Mar 30 ·
Impact: HIGH
Verde Cosmetic Labs LLC
Manufacturing adulterated finished pharmaceuticals
Why: CGMP violations in pharmaceutical manufacturing operations ·
Mar 30 ·
Impact: HIGH
premiumlightsupplier.com
Unlawful Schedule II stimulant sales over internet
Why: Controlled substances sold directly to consumers without proper licensing ·
Mar 30 ·
Impact: HIGH
UPSY LLC
Unapproved and misbranded COVID-19 related products
Why: Marketing unapproved COVID-19 products without FDA authorization ·
Mar 28 ·
Impact: HIGH
Cureganics
Unapproved COVID-19 products with misbranding
Why: Making unauthorized therapeutic claims for organic products ·
Mar 28 ·
Impact: HIGH
CBD Social
Unapproved COVID-19 products with misbranding
Why: Marketing CBD products with unauthorized COVID-19 claims ·
Mar 28 ·
Impact: HIGH
Functional Remedies, LLC D/B/A Synchronicity Hemp Oil
Unapproved COVID-19 products with misbranding
Why: Making unauthorized therapeutic claims for hemp products ·
Mar 28 ·
Impact: HIGH
Selected medium-impact items
LECS USA Inc.
Foreign supplier verification program non-compliance
Why: Inadequate supplier assessment or verification documentation ·
Mar 28 ·
Impact: MEDIUM
Bhan Kanom Thai Inc
Foreign supplier verification program violations
Why: Inadequate verification procedures for imported food suppliers ·
Mar 28 ·
Impact: MEDIUM
Madras Groceries
Foreign supplier verification program violations
Why: Inadequate verification and control of imported food suppliers ·
Mar 28 ·
Impact: MEDIUM
Transphere, Inc.
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention Act ·
Mar 28 ·
Impact: MEDIUM
Seacoi Investments, Inc. d/b/a Miura Cigars
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention Act ·
Mar 28 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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