Summary
High-impact items this period
Chaur Fong Inc. dba 888 Food Company
Seafood prepared under insanitary conditions, HACCP violations
Why: Non-compliance with seafood HACCP and CGMP food safety standards ·
Jul 29 ·
Impact: HIGH
The Royal Ice Cream Company Inc.
Food prepared under insanitary conditions with L. monocytogenes
Why: CGMP and food safety violations, pathogenic contamination detected ·
Jul 28 ·
Impact: HIGH
Vitti Labs, LLC
HCT/P regulatory deviations in human cells and tissues handling
Why: Non-compliance with CFR regulations for human cellular products ·
Jul 28 ·
Impact: HIGH
Sagent Pharmaceuticals, Inc.
CGMP violations in drug manufacturing operations
Why: Adulterated drugs from inadequate manufacturing and quality controls ·
Jul 27 ·
Impact: HIGH
Jose Miguel Gutierrez Salas
Unapproved drug distribution and registration violations
Why: Marketing unapproved pharmaceuticals without proper registration and listing ·
Jul 21 ·
Impact: HIGH
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.
Refusal to provide FDA access to records and documentation
Why: Non-compliance with FDA inspection authority and record access requirements ·
Jul 20 ·
Impact: HIGH
DSP Skin Care LLC
Pharmaceutical CGMP violations with adulterated product
Why: Current Good Manufacturing Practice non-compliance in finished pharmaceuticals ·
Jul 19 ·
Impact: HIGH
Jost Chemical Co.
API active pharmaceutical ingredient CGMP adulteration violations
Why: Failure to maintain current good manufacturing practices for APIs ·
Jul 18 ·
Impact: HIGH
Daniel Fred Goodman, M.D./Goodman Eye Center
IRB and bioresearch monitoring program violations
Why: Institutional Review Board oversight and compliance failures ·
Jul 14 ·
Impact: HIGH
Zyno Medical LLC
Manufacturing adulterated medical devices
Why: CGMP/QSR violations resulted in adulterated medical device production ·
Jul 12 ·
Impact: HIGH
Selected medium-impact items
Deggeh Foods, Inc.
Marketed unapproved new drugs; product misbranded
Why: Drug products marketed without approval and with improper labeling ·
Jul 29 ·
Impact: MEDIUM
EH Maldonado and Company
Foreign supplier verification program deficiencies
Why: Inadequate verification of imported food supplier safety controls ·
Jul 28 ·
Impact: MEDIUM
Tiger Vapor, LLC
Tobacco Control Act violations: adulterated misbranded vaping
Why: Distributing unapproved adulterated tobacco vaping products ·
Jul 25 ·
Impact: MEDIUM
Bacocas Enterprises Inc.
Foreign supplier verification program deficiencies
Why: Inadequate supplier verification procedures for imported food products ·
Jul 25 ·
Impact: MEDIUM
Muscle Feast, LLC
Adulterated dietary supplement CGMP manufacturing violations
Why: Non-compliance with manufacturing and labeling standards ·
Jul 22 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →