Summary
High-impact items this period
Duong Ha Processing Trading Seafood Company Limited
Seafood HACCP and adulteration violation
Why: Seafood processing failed hazard analysis critical control points ·
Nov 26 ·
Impact: HIGH
Becton, Dickinson, and Company/CareFusion 303, Inc.
Medical device CGMP and QSR violations with adulteration
Why: Quality system failures in device manufacturing and labeling ·
Nov 22 ·
Impact: HIGH
Mid America Pet Food LLC
Animal food produced under insanitary CGMP conditions
Why: Inadequate sanitation and contamination controls in manufacturing ·
Nov 22 ·
Impact: HIGH
Dr. Brite, LLC
CGMP violations in finished pharmaceuticals manufacturing
Why: Adulterated products from inadequate quality control systems ·
Nov 21 ·
Impact: HIGH
LCC Ltd.
Adulterated unapproved misbranded pharmaceutical violations
Why: CGMP failures, unapproved new drugs, and misbranding in pharmaceuticals ·
Nov 21 ·
Impact: HIGH
Catwalk Cosmetic Laboratories Pty Ltd.
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice non-compliance in pharmaceutical production ·
Nov 21 ·
Impact: HIGH
Eurosirel S.P.A
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice non-compliance in pharmaceutical production ·
Nov 20 ·
Impact: HIGH
Hangzhou Huiji Biotechnology Co., Ltd.
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice non-compliance in pharmaceutical production ·
Nov 18 ·
Impact: HIGH
Breadbox Co.
Seafood HACCP adulteration and insanitary conditions
Why: Failure to implement seafood safety protocols and maintain sanitary conditions ·
Nov 18 ·
Impact: HIGH
Centura Pharmaceuticals Inc
Unapproved drug; misbranded OTC pharmaceutical product
Why: Marketing unapproved drug or misrepresenting OTC drug status ·
Nov 15 ·
Impact: HIGH
Selected medium-impact items
Stew Leonard’s Holdings LLC
Misbranded food labeling violations
Why: Non-compliant food product labeling and consumer disclosure requirements ·
Nov 18 ·
Impact: MEDIUM
Western Innovations, Inc.
Dietary supplement CGMP adulteration violation
Why: Supplement manufacturing failed current good manufacturing practices ·
Nov 13 ·
Impact: MEDIUM
Nutrition Strength Ltd.
Animal drug product adulterated; unapproved new animal drug
Why: Violation of animal drug approval requirements and CGMP standards ·
Nov 12 ·
Impact: MEDIUM
HDFrenchies LLC dba Bully Baum
New animal drug adulterated violation
Why: Pet product failed to meet FDA safety or quality standards ·
Nov 12 ·
Impact: MEDIUM
Veterinary Select Formula dba Allergic Pet
Animal drug product adulterated; unapproved new animal drug
Why: Violation of animal drug approval requirements and CGMP standards ·
Nov 12 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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