Summary
High-impact items this period
Les Importations Herbasanté Inc.
Pharmaceutical finished products adulterated CGMP violations
Why: Current Good Manufacturing Practice non-compliance in pharmaceutical production ·
Jan 31 ·
Impact: HIGH
Barsotti Juice Company, Inc.
Juice HACCP violations and insanitary conditions detected
Why: Manufacturing facility failed to maintain sanitary conditions and proper HACCP protocols ·
Jan 30 ·
Impact: HIGH
Inmar Supply Chain Solutions, LLC
Food adulterated from insanitary manufacturing and handling
Why: Failure to maintain sanitary conditions during food manufacturing and packing ·
Jan 30 ·
Impact: HIGH
Soulaire Corporation
Investigational device exemption adulterated device violation
Why: Device failed to meet safety or performance standards during IDE/PMA process ·
Jan 29 ·
Impact: HIGH
Nobles Medical Technology II, Inc.
Investigational review board compliance violations
Why: IRB oversight deficiencies in clinical investigations ·
Jan 26 ·
Impact: HIGH
S & J International Enterprises Public Company Limited
CGMP violation - adulterated finished pharmaceutical products
Why: Manufacturing process failures or quality control deficiencies in drug production ·
Jan 26 ·
Impact: HIGH
QuVa Pharma, Inc.
Compounding pharmacy produced adulterated drug products
Why: Violation of compounding pharmacy CGMP standards ·
Jan 26 ·
Impact: HIGH
Lucky K.T. Co., Inc.
CGMP violations and insanitary manufacturing conditions
Why: Unsanitary conditions in food manufacturing, packing or holding operations ·
Jan 26 ·
Impact: HIGH
Agila Corporation dba Woody’s Pet Food Deli
CGMP and preventive controls violations in pet food manufacturing
Why: Pet food facility failed hazard analysis and preventive control protocols ·
Jan 26 ·
Impact: HIGH
Colgin, Inc.
CGMP violations in finished pharmaceutical operations
Why: Manufacturing facility failed to maintain current good manufacturing practices ·
Jan 25 ·
Impact: HIGH
Selected medium-impact items
Barkey GmbH & Co. KG
Investigational device exemption and premarket approval violations
Why: Non-compliance with IDE/PMA regulatory requirements ·
Jan 31 ·
Impact: MEDIUM
Cheap MistHub
Tobacco product adulteration and misbranding violation
Why: Unapproved tobacco product claims or prohibited marketing practices ·
Jan 31 ·
Impact: MEDIUM
Nico Choice LLC
Tobacco product adulteration and misbranding violation
Why: Unapproved tobacco product claims or prohibited marketing practices ·
Jan 31 ·
Impact: MEDIUM
AT Vapors LLC
Tobacco product adulteration and misbranding violation
Why: Unapproved tobacco product claims or prohibited marketing practices ·
Jan 31 ·
Impact: MEDIUM
Vapingfly
Tobacco product adulteration and misbranding violation
Why: Unapproved tobacco product claims or prohibited marketing practices ·
Jan 31 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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