Summary
High-impact items this period
Woorilife & Health
Adulterated finished pharmaceuticals manufacturing non-compliance
Why: CGMP violations in pharmaceutical product manufacturing quality ·
Dec 28 ·
Impact: HIGH
East Fork Cultivars
Unapproved new drug distributed and misbranded
Why: Selling unapproved botanical pharmaceutical products without FDA approval ·
Dec 22 ·
Impact: HIGH
Wipro Unza Singapore Private, Limited
Refusal to provide records access to FDA inspectors
Why: Non-cooperation with regulatory inspection and document requests ·
Dec 21 ·
Impact: HIGH
Curtis Jacquot dba Pacific BioLogic Co.
Dietary supplement CGMP violations and adulteration
Why: Non-compliance with current good manufacturing practices for dietary supplements ·
Dec 21 ·
Impact: HIGH
Botanical Be
Unapproved new drug distributed and misbranded
Why: Marketing botanical products as drugs without FDA approval ·
Dec 21 ·
Impact: HIGH
MiMedx Group, Inc.
HCT/P deviations from CFR regulations
Why: Non-compliance with human cells, tissues, and cellular products regulations ·
Dec 20 ·
Impact: HIGH
Hua Da Trading, Inc.
Unapproved new drug distributed and misbranded
Why: Marketing pharmaceuticals without FDA approval and improper labeling ·
Dec 20 ·
Impact: HIGH
Amazon.com, Inc.
Unapproved new drug marketplace distribution and misbranding
Why: Platform failed to prevent sale of non-approved pharmaceuticals ·
Dec 20 ·
Impact: HIGH
Inopak, Ltd.
Adulterated finished pharmaceuticals manufacturing non-compliance
Why: CGMP violations in pharmaceutical manufacturing and quality systems ·
Dec 15 ·
Impact: HIGH
Iowa Egg Company Inc.
Shell egg regulation violations producing adulterated product
Why: Failure to comply with PHS Act shell egg safety regulations ·
Dec 15 ·
Impact: HIGH
Selected medium-impact items
My Vape Shack
Marketed adulterated and misbranded tobacco products violating FSPTCA
Why: Distributed unapproved tobacco vaping products without proper FDA compliance ·
Dec 21 ·
Impact: MEDIUM
Vaproma Inc.
Marketed adulterated and misbranded tobacco products violating FSPTCA
Why: Distributed unapproved tobacco vaping products without proper FDA compliance ·
Dec 20 ·
Impact: MEDIUM
Vape-X Club
Marketed adulterated and misbranded tobacco products violating FSPTCA
Why: Distributed unapproved tobacco vaping products without proper FDA compliance ·
Dec 20 ·
Impact: MEDIUM
Samuel Rodriguez dba KiloKennelzz
Unapproved new animal drug distribution
Why: Marketing adulterated animal drugs without FDA approval ·
Dec 20 ·
Impact: MEDIUM
Disposable Vapez
Marketed adulterated and misbranded tobacco products violating FSPTCA
Why: Distributed unapproved tobacco vaping products without proper FDA compliance ·
Dec 20 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →