Summary
High-impact items this period
DRG Instruments GmbH
IDE/PMA violations with adulterated investigational device
Why: Investigational device failed premarket requirements and approval ·
Mar 31 ·
Impact: HIGH
Yiling Pharmaceutical Ltd.
CGMP violation in finished pharmaceuticals adulterated product
Why: Manufacturing process failures leading to adulterated pharmaceutical products ·
Mar 27 ·
Impact: HIGH
BioAsia Worldwide Sdn Bhd
CGMP violations in finished pharmaceutical manufacturing
Why: Manufacturing facility failed current good manufacturing practice requirements ·
Mar 25 ·
Impact: HIGH
Latro Inc.
Adulterated and misbranded human food products
Why: Food safety violations in manufacturing or sourcing ·
Mar 25 ·
Impact: HIGH
United Health Products, Inc.
Bioresearch Monitoring IRB compliance violations
Why: Institutional Review Board process failures in clinical research oversight ·
Mar 24 ·
Impact: HIGH
Macsen Drugs
Pharmaceutical adulteration CGMP violations
Why: Current Good Manufacturing Practice violations in finished drugs ·
Mar 05 ·
Impact: HIGH
ProRx, LLC
Adulterated drug products from compounding pharmacy
Why: Quality control failures in compounded pharmaceutical preparations ·
Mar 04 ·
Impact: HIGH
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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