Summary
High-impact items this period
www.alphamedstore.com
Unapproved new pharmaceutical drugs marketed as misbranded products
Why: Distribution of unapproved pharmaceutical products without proper authorization ·
Sep 29 ·
Impact: HIGH
Spectrum Medical Ltd
Medical devices adulterated; CGMP and QSR violations
Why: Failed to maintain current good manufacturing and quality system practices ·
Sep 29 ·
Impact: HIGH
GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC dba Hemp XR
Unapproved botanical products adulterated without premarket approval
Why: Marketing adulterated products lacking required premarket approval authorization ·
Sep 28 ·
Impact: HIGH
Antonio E. Blanco, M.D./Vista Health Research, LLC
Clinical investigator compliance violations in drug trials
Why: Failure to meet FDA clinical investigator regulatory standards ·
Sep 26 ·
Impact: HIGH
Sonesta Medical AB
CGMP/QSR violations and adulterated medical device manufacturing
Why: Failed to maintain current good manufacturing practices for medical devices ·
Sep 22 ·
Impact: HIGH
Raven Route
Tobacco products adulterated/misbranded under FSPTCA
Why: Non-compliant tobacco product manufacturing or distribution practices ·
Sep 20 ·
Impact: HIGH
P.T. Sankei Medical Industries
Medical devices adulterated; CGMP and QSR violations
Why: Failed to maintain current good manufacturing and quality system practices ·
Sep 19 ·
Impact: HIGH
Hygienic Labs, LLC
Refused to provide access to records
Why: Failure to comply with FDA inspection and record access requirements ·
Sep 19 ·
Impact: HIGH
Curexa – East, LLC dba Curexa
Compounding pharmacy produced adulterated drug products
Why: Failure to maintain quality standards in pharmaceutical compounding ·
Sep 13 ·
Impact: HIGH
Desserts by Helen, Inc.
Food adulteration from insanitary preparation and storage
Why: CGMP violations in food handling and sanitary conditions ·
Sep 11 ·
Impact: HIGH
Selected medium-impact items
Kari-Fresh LLC
Foreign supplier verification program non-compliance
Why: Failure to implement adequate supplier verification procedures for imports ·
Sep 29 ·
Impact: MEDIUM
Apollo Import Export, Inc.
Foreign supplier verification program FSVP non-compliance
Why: Failure to implement adequate foreign food supplier verification procedures ·
Sep 26 ·
Impact: MEDIUM
Kyawkhin Inc.
Foreign supplier verification program non-compliance
Why: Failure to properly verify imported food product suppliers ·
Sep 20 ·
Impact: MEDIUM
Shantaba LLC
Foreign supplier verification program non-compliance
Why: Failure to implement adequate supplier verification procedures for imports ·
Sep 08 ·
Impact: MEDIUM
Kimera Labs, Inc.
Investigational device exemption violations
Why: Non-compliance with IDE requirements for experimental medical devices ·
Sep 01 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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