Summary
High-impact items this period
Evolutionary Biologics Inc.
HCT/P regulatory deviations for cellular tissue products
Why: Non-compliance with human cell tissue product regulations ·
Dec 30 ·
Impact: HIGH
Reunipeche SAS
Seafood HACCP and food CGMP compliance failures
Why: Adulterated seafood due to inadequate hazard controls ·
Dec 26 ·
Impact: HIGH
Baldwin Richardson Foods Pennsauken, LLC
Low acid canned food safety regulation violations
Why: Adulterated canned food products due to inadequate processing controls ·
Dec 26 ·
Impact: HIGH
Nyumbani Hakuna Matata LLC
Seafood HACCP adulteration under insanitary conditions
Why: Seafood processing failed sanitation and HACCP requirements ·
Dec 23 ·
Impact: HIGH
Rey de los Camarones S. A.
Seafood HACCP and CGMP compliance failures
Why: Adulterated seafood due to inadequate hazard prevention ·
Dec 23 ·
Impact: HIGH
By George Food Specialties Inc.
Foreign supplier verification program violation
Why: Failed to adequately verify foreign food supplier safety ·
Dec 23 ·
Impact: HIGH
Golden Grains Bakery
CGMP and preventive controls violations in food manufacturing
Why: Adulterated food due to inadequate hazard analysis controls ·
Dec 20 ·
Impact: HIGH
Fagron Compounding Services, LLC dba Fagron Sterile Service
Adulterated drug products from compounding pharmacy
Why: Quality control and manufacturing failures in sterile preparations ·
Dec 19 ·
Impact: HIGH
Integra LifeSciences Corporation
Medical device CGMP quality system violation
Why: Device manufacturing failed current good manufacturing practices ·
Dec 19 ·
Impact: HIGH
Viatris, Inc.
Finished pharmaceutical product adulterated via CGMP violations
Why: Current Good Manufacturing Practice deficiencies in production processes ·
Dec 19 ·
Impact: HIGH
Selected medium-impact items
JBRANDS LLC
Tobacco product adulterated or misbranded under FSPTCA
Why: Violation of Family Smoking Prevention and Tobacco Control Act regulations ·
Dec 19 ·
Impact: MEDIUM
Vape Mania
Tobacco product adulterated or misbranded under FSPTCA
Why: Violation of Family Smoking Prevention and Tobacco Control Act regulations ·
Dec 18 ·
Impact: MEDIUM
Jai Guruji LLC d/b/a Vape Marley
Tobacco product adulterated or misbranded under FSPTCA
Why: Violation of Family Smoking Prevention and Tobacco Control Act regulations ·
Dec 18 ·
Impact: MEDIUM
Vapezilla LLC
Tobacco product adulterated or misbranded under FSPTCA
Why: Violation of Family Smoking Prevention and Tobacco Control Act regulations ·
Dec 18 ·
Impact: MEDIUM
E-liquid Brands, LLC
Tobacco product adulterated or misbranded under FSPTCA
Why: Violation of Family Smoking Prevention and Tobacco Control Act regulations ·
Dec 18 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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