Summary
High-impact items this period
Cohance Lifesciences Limited
CGMP violations resulting in adulterated finished pharmaceuticals
Why: Manufacturing process defects or contamination in pharmaceutical production ·
Jan 30 ·
Impact: HIGH
Diasol, Inc.
Investigational Device Exemption and PMA violations
Why: Non-compliance with IDE requirements or unauthorized device marketing ·
Jan 29 ·
Impact: HIGH
Central Coast Multispecialty Medical Group, Inc.
HCT/P regulations violations in human cells and tissues handling
Why: Deviations from CFR requirements for cellular and tissue product operations ·
Jan 29 ·
Impact: HIGH
Beta Bionics, Inc.
Medical device CGMP and Quality System Regulation violations
Why: Manufacturing and quality control failures for adulterated devices ·
Jan 28 ·
Impact: HIGH
HTO Nevada, Inc. dba Kirkman
CGMP violations resulting in adulterated finished pharmaceuticals
Why: Manufacturing process failures or contamination in pharmaceutical production ·
Jan 27 ·
Impact: HIGH
Conceive Fertility Center
HCT/P regulations violations in human cells and tissues handling
Why: Deviations from CFR requirements for reproductive tissue operations ·
Jan 27 ·
Impact: HIGH
Flextronics America LLC
CGMP and QSR violations in medical device manufacturing
Why: Quality system deficiencies in device component production or assembly ·
Jan 27 ·
Impact: HIGH
Louisville Reproductive Center
HCT/P deviations and CFR regulatory non-compliance
Why: Failure to meet human cells, tissues, and cellular products regulations ·
Jan 23 ·
Impact: HIGH
Abbott Diabetes Care, Inc.
CGMP and QSR violations in medical device manufacturing
Why: Quality control failures in diabetes monitoring device production ·
Jan 23 ·
Impact: HIGH
Signature Formulations, LLC
CGMP violations resulting in adulterated finished pharmaceuticals
Why: Manufacturing process failures or quality system deficiencies ·
Jan 21 ·
Impact: HIGH
Selected medium-impact items
gotpouches.com
Tobacco product misbranding and adulteration violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Jan 30 ·
Impact: MEDIUM
niqpouches.com
Tobacco product misbranding and adulteration violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Jan 30 ·
Impact: MEDIUM
Fidelity Melon, Inc
Foreign Supplier Verification Program compliance failures
Why: Inadequate verification and monitoring of foreign food suppliers ·
Jan 29 ·
Impact: MEDIUM
Tombak LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jan 22 ·
Impact: MEDIUM
East CK Trading Inc.
Foreign Supplier Verification Program compliance failures
Why: Inadequate verification procedures for foreign food ingredient suppliers ·
Jan 16 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →