Summary
High-impact items this period
Russ Davis Wholesale Inc
Juice HACCP non-compliance and insanitary conditions
Why: Juice processing facility failing HACCP and CGMP sanitation standards ·
Apr 28 ·
Impact: HIGH
DLG Naturals, Inc.
Unapproved new drug misbranding violations
Why: Marketing dietary supplement as unapproved drug without authorization ·
Apr 28 ·
Impact: HIGH
Cigsweb.com
Tobacco product adulterated or misbranded without approval
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Apr 26 ·
Impact: HIGH
MCACO, LTD
Dietary supplement CGMP and adulteration violations
Why: Failure to comply with current good manufacturing practices for dietary supplements ·
Apr 21 ·
Impact: HIGH
Miami University Department of Chemistry and Biochemistry
Active pharmaceutical ingredients manufactured without CGMP compliance
Why: Academic institution failed to maintain GMP standards for API production ·
Apr 20 ·
Impact: HIGH
Thai Union Group PLC
Seafood HACCP and CGMP violations with Listeria contamination
Why: Inadequate sanitary conditions and hazard analysis procedures ·
Apr 20 ·
Impact: HIGH
C R Supplements, LLC
Unapproved new drugs marketed as supplements
Why: Misbranded supplement products with drug claims ·
Apr 20 ·
Impact: HIGH
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
Unapproved pharmaceuticals sold as adulterated misbranded products
Why: Marketing unproven drugs without FDA approval and inadequate labeling ·
Apr 19 ·
Impact: HIGH
Kleenhanz, LLC
Unapproved COVID-19 related drug products marketed
Why: Marketing unproven treatments without FDA authorization during pandemic ·
Apr 19 ·
Impact: HIGH
Fresh Farms LLC
Pharmaceutical products manufactured without CGMP compliance
Why: Failure to implement current good manufacturing practice requirements ·
Apr 19 ·
Impact: HIGH
Selected medium-impact items
Beachside Vapors LLC
Adulterated/misbranded tobacco products
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Apr 29 ·
Impact: MEDIUM
Allure Foods LLC
Foreign supplier verification program inadequate controls
Why: Failed to implement adequate FSVP procedures for imported food ·
Apr 27 ·
Impact: MEDIUM
Smoke-Free Planet, LLC d/b/a Smoke Free Nation
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Apr 27 ·
Impact: MEDIUM
Cigsway
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Apr 26 ·
Impact: MEDIUM
El Dorado Imports Inc
Foreign supplier verification program non-compliance
Why: Inadequate supplier assessment or verification documentation ·
Apr 26 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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