Summary
High-impact items this period
Strukmyer LLC dba Strukmyer Medical
Adulterated finished pharmaceuticals CGMP violations
Why: Manufacturing process non-compliance in pharmaceutical products ·
Jan 30 ·
Impact: HIGH
AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp
Finished pharmaceutical product adulteration CGMP violation
Why: Current Good Manufacturing Practice non-compliance in finished drug production ·
Jan 29 ·
Impact: HIGH
Shantou Kangjie Daily Chemical Industry Co., Ltd
Adulterated finished pharmaceuticals CGMP violations
Why: Manufacturing deficiencies in finished pharmaceutical production ·
Jan 28 ·
Impact: HIGH
Garcia Fresh Vegetables LLC
Foreign supplier verification program FSVP non-compliance
Why: Inadequate supplier verification and food safety controls for imports ·
Jan 27 ·
Impact: HIGH
Imperial Palace Commodity -Dongguan- Co., Ltd.
Adulterated finished pharmaceuticals CGMP violations
Why: Manufacturing process non-compliance in finished drug products ·
Jan 27 ·
Impact: HIGH
Center for Instrumental Analysis of China Pharmaceutical University
Adulterated active pharmaceutical ingredient CGMP violations
Why: Manufacturing deficiencies in API production quality standards ·
Jan 23 ·
Impact: HIGH
Kardesler Ucan Yaglar Sanayi Anonim Sirketi
Adulterated finished pharmaceutical CGMP violations
Why: Manufacturing process deviations compromising pharmaceutical integrity ·
Jan 21 ·
Impact: HIGH
Robbins Instruments, LLC
Medical device misbranded, unapproved, QSR violations
Why: Quality system regulation and device approval pathway non-compliance ·
Jan 21 ·
Impact: HIGH
Chara Biologics, Inc.
CGMP deviations in biologics license application manufacturing
Why: Manufacturing process non-compliance for licensed biologic products ·
Jan 17 ·
Impact: HIGH
BioStem Life Sciences
HCT/P regulatory deviations for cellular tissue products
Why: Non-compliance with human cell tissue product CFR requirements ·
Jan 17 ·
Impact: HIGH
Selected medium-impact items
Talla Imports, LLC
Foreign supplier verification program non-compliance
Why: Inadequate verification procedures for imported food/drug products ·
Jan 13 ·
Impact: MEDIUM
Elite Brothers, LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Tobacco Control Act requirements ·
Jan 07 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →