Summary
High-impact items this period
Nefeteri Wellness
Unapproved new drugs marketed without FDA authorization
Why: Selling drug products lacking required FDA approval ·
May 30 ·
Impact: HIGH
Marin Baking LLC
Food prepared, packed, held under insanitary conditions
Why: Facility sanitation deficiencies in bakery operations ·
May 28 ·
Impact: HIGH
Voehlganic Farm LLC
Shell egg production adulteration and safety violations
Why: Non-compliance with PHS Act shell egg safety regulations ·
May 28 ·
Impact: HIGH
Aju Pharm Co., Ltd.
Medical device CGMP/QSR violations; adulterated products
Why: Manufacturing quality system deficiencies in device production ·
May 21 ·
Impact: HIGH
denverelectroniccigarettes.com
Tobacco products adulterated and misbranded violating control act
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act regulations ·
May 16 ·
Impact: HIGH
AACE Pharmaceuticals, Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Adulterated pharmaceuticals due to manufacturing quality failures ·
May 13 ·
Impact: HIGH
Kabe Labortechnik GmbH
CGMP/QSR violations in medical device manufacturing
Why: Adulterated medical devices due to quality system deficiencies ·
May 09 ·
Impact: HIGH
NeuroSync, Inc.
Medical device CGMP and QSR adulteration violations
Why: Quality System Regulation and manufacturing practice failures in device production ·
May 09 ·
Impact: HIGH
Microspecialties, LLC
Medical device CGMP and QSR adulteration violations
Why: Quality System Regulation and manufacturing practice failures in device production ·
May 08 ·
Impact: HIGH
Product Society LLC
Finished pharmaceutical CGMP adulteration violations
Why: Current Good Manufacturing Practice violations in pharmaceutical manufacturing processes ·
May 08 ·
Impact: HIGH
Selected medium-impact items
Bad Drip Labs Inc.
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
May 29 ·
Impact: MEDIUM
Grow Gold Land, Inc.
Foreign supplier verification program non-compliance
Why: Inadequate verification of imported food suppliers ·
May 27 ·
Impact: MEDIUM
Kure CBD & Vape
Tobacco product violations including adulteration and misbranding
Why: Violation of Family Smoking Prevention and Tobacco Control Act ·
May 22 ·
Impact: MEDIUM
Artisan Vapor Company
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
May 22 ·
Impact: MEDIUM
vapordna.com
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
May 16 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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