Summary
High-impact items this period
Re-Gen Active Lab, Inc.
HCT/P regulatory deviation and CFR non-compliance
Why: Human cells/tissues product handling violations and regulatory deviations ·
May 27 ·
Impact: HIGH
Smitha C. Reddy, M.D./ACRC Studies, LLC
Clinical investigator protocol compliance violations
Why: Deviations from clinical investigation regulations and requirements ·
May 27 ·
Impact: HIGH
Haniel Concepts, Inc. DBA Free State Oils, LLC
Unapproved CBD products marketed illegally
Why: Selling CBD products with unauthorized drug claims ·
May 26 ·
Impact: HIGH
Hope Botanicals, LLC
Unapproved CBD products marketed as drugs
Why: Selling CBD products without FDA approval as drug claims ·
May 26 ·
Impact: HIGH
Plantacea, LLC dba Kahm
Unapproved CBD products marketed without authorization
Why: Distributing misbranded CBD products making drug claims ·
May 26 ·
Impact: HIGH
Aire-Master of America, Inc.
Finished pharmaceutical product CGMP adulteration
Why: Current Good Manufacturing Practice violations in production ·
May 23 ·
Impact: HIGH
Grimann S.A. de C.V.
Failed drug registration and listing requirements
Why: Non-compliance with FDA drug establishment registration and listing ·
May 23 ·
Impact: HIGH
MMWTA Mothers Milk WTA
Tobacco product adulterated or misbranded under FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
May 20 ·
Impact: HIGH
Santhigram Kerala Ayurvedic Co. of U.S., Inc.
Sale and distribution of unapproved new drugs
Why: Marketing unapproved Ayurvedic products as pharmaceutical drugs ·
May 19 ·
Impact: HIGH
New Vitalis, LLC dba New Vitalis Pharmacy
Compounding pharmacy producing adulterated drug products
Why: Pharmacy compounding violations producing contaminated medications ·
May 18 ·
Impact: HIGH
Selected medium-impact items
Daxa Foods, Inc. dba India Grocers
Foreign supplier verification program violations
Why: Failure to implement adequate FSVP procedures ·
May 31 ·
Impact: MEDIUM
Export Guatemala Corporation
Inadequate foreign supplier verification procedures
Why: Failure to comply with FSVP requirements for imported food products ·
May 31 ·
Impact: MEDIUM
Dara Food LLC
FSVP non-compliance for foreign supplier verification
Why: Failure to implement adequate foreign supplier verification program ·
May 31 ·
Impact: MEDIUM
BonZer BrandZ LLC d/b/a BonZer VapeZ, LLC
Tobacco product adulterated/misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
May 27 ·
Impact: MEDIUM
Freeman and Biddy, LLC d/b/a Freedom Vapes
Tobacco products adulterated and misbranded
Why: Non-compliant vapor products violating tobacco control regulations ·
May 26 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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