Summary
High-impact items this period
Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.
Human cells/tissues regulatory deviation and CFR violations
Why: Non-compliance with HCT/P regulations and quality standards ·
Jun 28 ·
Impact: HIGH
Baylab USA, LLC
Adulterated medical device under IDE/PMA development pathway
Why: Quality failures in investigational or premarket approval device applications ·
Jun 27 ·
Impact: HIGH
Discover Fresh Foods, LLC
Insanitary conditions and L. monocytogenes contamination in food
Why: Inadequate sanitation leading to pathogenic bacterial contamination ·
Jun 26 ·
Impact: HIGH
reBom Co., Ltd.
Pharmaceutical CGMP violations resulting in adulterated products
Why: Manufacturing practice deviations in pharmaceutical production ·
Jun 26 ·
Impact: HIGH
AMCO International Manufacturing & Design, Inc.
Manufacturing and distribution of unapproved medical devices
Why: Operating without FDA approval and clearance for device products ·
Jun 25 ·
Impact: HIGH
Natural Ginger, Corp/Jonaus Corp
New drug product misbranded without required approval
Why: Marketing unapproved drug claims or missing proper labeling information ·
Jun 25 ·
Impact: HIGH
Donggang Wanrui Food Co., Ltd.
Seafood HACCP and CGMP violations with adulterated product
Why: Failure to implement seafood hazard analysis and manufacturing controls ·
Jun 25 ·
Impact: HIGH
Sakhon Wattana Thang Chue Hah
Seafood HACCP and CGMP violations with adulterated product
Why: Non-compliance with seafood hazard analysis and current good manufacturing practices ·
Jun 25 ·
Impact: HIGH
Ozempen.com
Unlawful sale of unapproved misbranded drugs via internet
Why: Selling prescription drugs without FDA approval to US consumers online ·
Jun 24 ·
Impact: HIGH
Advance Nature Sdn Bhd
Adulterated low acid canned food regulatory violations
Why: Low acid canned food regulation non-compliance and adulteration ·
Jun 24 ·
Impact: HIGH
Selected medium-impact items
Alien Vape LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 28 ·
Impact: MEDIUM
Key Foods Co. dba Key Food Services
Foreign Supplier Verification Program compliance failures
Why: Inadequate supplier verification and safety controls ·
Jun 27 ·
Impact: MEDIUM
Warlock Vapes, LLC d/b/a Zuluvape
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 27 ·
Impact: MEDIUM
JC Finest Produce Inc
Failure to verify foreign supplier food safety
Why: Non-compliance with Foreign Supplier Verification Program requirements ·
Jun 24 ·
Impact: MEDIUM
Massachusetts Institute of Technology MIT
Bioresearch monitoring and institutional review board deficiencies
Why: IRB oversight failures in clinical research protocol review and oversight ·
Jun 21 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →