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FDA Enforcement — April 2022 Report

Automated analysis of 54 items from public government data sources. Updated daily.

Summary

54
Total items
33
High impact
21
Medium impact
0
Low impact

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. Full methodology →