Summary
High-impact items this period
Absolutely Natural
Adulterated finished pharmaceuticals manufacturing violations
Why: CGMP non-compliance in finished pharmaceutical production ·
Dec 30 ·
Impact: HIGH
R.R. Importaciones Inc.
Foreign Supplier Verification Program non-compliance
Why: Inadequate verification and control of imported food sources ·
Dec 30 ·
Impact: HIGH
Tower Laboratories Ltd.
Adulterated finished pharmaceuticals manufacturing violations
Why: CGMP non-compliance in finished pharmaceutical production ·
Dec 23 ·
Impact: HIGH
Chemspec Chemicals Private Limited
Adulterated active pharmaceutical ingredient manufacturing
Why: API CGMP non-compliance in production controls ·
Dec 23 ·
Impact: HIGH
Meridian Bioscience, Inc
Medical device CGMP/QSR violations and adulteration
Why: Failure to maintain current good manufacturing practices for devices ·
Dec 22 ·
Impact: HIGH
Purushothaman Damodara Kumaran, M.D.
Clinical bioavailability-bioequivalence study compliance violations
Why: In vivo study protocol violations and investigator non-compliance ·
Dec 22 ·
Impact: HIGH
Agebox Inc.
Unapproved new drug product distribution and misbranding
Why: Marketing unapproved drug without regulatory approval ·
Dec 19 ·
Impact: HIGH
LiquidCapsule Manufacturing, LLC
Adulterated finished pharmaceuticals manufacturing violations
Why: CGMP non-compliance in finished pharmaceutical production ·
Dec 19 ·
Impact: HIGH
Exactech, Inc. dba Advita Ortho
CGMP/QSR violations in medical device manufacturing
Why: Adulterated medical devices due to quality system failures ·
Dec 19 ·
Impact: HIGH
Unipack LLC
Adulterated finished pharmaceuticals manufacturing violations
Why: CGMP non-compliance in finished pharmaceutical production ·
Dec 19 ·
Impact: HIGH
Selected medium-impact items
snuzyn.com
Adulterated and misbranded tobacco products
Why: Tobacco Control Act violations in product marketing ·
Dec 30 ·
Impact: MEDIUM
bongsociety.com
Adulterated and misbranded tobacco products
Why: Tobacco Control Act violations in product distribution ·
Dec 30 ·
Impact: MEDIUM
LXR Biotech, LLC
Adulterated and misbranded dietary supplement products
Why: CGMP violations in dietary supplement manufacturing ·
Dec 23 ·
Impact: MEDIUM
Private Label Skin Care, Inc.
Adulterated and misbranded OTC pharmaceutical products
Why: CGMP violations in OTC manufacturing and labeling ·
Dec 18 ·
Impact: MEDIUM
ShapeShifter Apparel, LLC
Failure to register and list device; product misbranded
Why: Medical device marketed without proper FDA registration and listing ·
Dec 16 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →