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FDA Enforcement — February 2024 Report

Automated analysis of 39 items from public government data sources. Updated daily.

Summary

39
Total items
24
High impact
15
Medium impact
0
Low impact

High-impact items this period

Cosmetic Specialty Labs, Inc.
CGMP violations in finished pharmaceutical production facility
Why: Manufacturing operations failed current good manufacturing practice requirements  ·  Feb 29  ·  Impact: HIGH
Native Salts LLC
Unapproved drug marketed without required FDA authorization
Why: Product sold with unapproved claims and misbranded as pharmaceutical  ·  Feb 28  ·  Impact: HIGH
Thai Nakorn Patana Co., Ltd.
CGMP violations in finished pharmaceutical manufacturing
Why: Manufacturing facility failed to meet current good manufacturing practice standards  ·  Feb 27  ·  Impact: HIGH
Royal Philips
Medical device CGMP violations and adulterated products
Why: Manufacturing facility failed quality system regulations and CGMP standards  ·  Feb 23  ·  Impact: HIGH
Innovative Formulations, LLC dba Insane Labz
Unapproved new drug marketed as finished pharmaceutical
Why: Product sold without FDA approval and misbranded labeling  ·  Feb 22  ·  Impact: HIGH
Higley Industries, Inc.
Adulterated pharmaceutical product CGMP violations
Why: Manufacturing quality control and process deficiencies  ·  Feb 22  ·  Impact: HIGH
LightEyez Limited
Finished pharmaceutical CGMP violations and unapproved new drug
Why: Manufacturing and marketing adulterated unapproved pharmaceuticals non-compliantly  ·  Feb 15  ·  Impact: HIGH
Bell International Laboratories, Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Manufacturing facility failed to maintain current good manufacturing practices  ·  Feb 15  ·  Impact: HIGH
Amman Pharmaceutical Industries
Finished pharmaceutical CGMP violations producing adulterated drugs
Why: Manufacturing finished pharmaceuticals in non-compliant conditions  ·  Feb 14  ·  Impact: HIGH
EzriCare LLC
Finished pharmaceutical CGMP violations producing adulterated drugs
Why: Manufacturing finished pharmaceuticals in non-compliant conditions  ·  Feb 13  ·  Impact: HIGH

Selected medium-impact items

The Vape Zone LLC
Tobacco product misbranding and adulteration violations
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act  ·  Feb 29  ·  Impact: MEDIUM
Cencal Vape, Inc.
Tobacco product misbranding and adulteration violations
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act  ·  Feb 27  ·  Impact: MEDIUM
Vapemarkdown.com
Tobacco product misbranding and adulteration violations
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act  ·  Feb 27  ·  Impact: MEDIUM
Vapemoreinc.com, Inc.
Tobacco product misbranding and adulteration violations
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act  ·  Feb 27  ·  Impact: MEDIUM
Vape Papa
Tobacco product misbranding and adulteration violations
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act  ·  Feb 27  ·  Impact: MEDIUM

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Data sourced from public government APIs. AI analysis via Claude Haiku. Full methodology →