Summary
High-impact items this period
Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy
Compounding pharmacy producing adulterated drug products
Why: Manufacturing control deficiencies in compounding operations ·
Mar 31 ·
Impact: HIGH
ALI Pharmaceutical Manufacturing, LLC
Active pharmaceutical ingredient adulteration CGMP violation
Why: API manufacturing fails current good manufacturing practice standards ·
Mar 30 ·
Impact: HIGH
Sure-Biochem Laboratories, LLC
Current Good Manufacturing Practice violations in pharmaceuticals
Why: Adulterated finished pharmaceutical products due to manufacturing defects ·
Mar 24 ·
Impact: HIGH
Liberty Fruit Co. Inc. DBA Carol’s Cuts
Juice HACCP, CGMP violations; adulteration and insanitary conditions
Why: Unsanitary manufacturing conditions; product contamination risks ·
Mar 24 ·
Impact: HIGH
Synovo Production, Inc.
CGMP and quality system violations in medical device manufacturing
Why: Non-compliance with quality system regulation in device production ·
Mar 23 ·
Impact: HIGH
Tyrone L. McCall, M.D./Cornea Associates of Texas
Clinical investigator violations in drug research protocols
Why: Non-compliance with clinical trial conduct and data integrity requirements ·
Mar 22 ·
Impact: HIGH
Omega Packaging Corp
CGMP violations in finished pharmaceutical manufacturing
Why: Quality control deficiencies in pharmaceutical product packaging and production ·
Mar 20 ·
Impact: HIGH
Old Europe Cheese, Inc.
Cheese produced under insanitary conditions causing adulteration
Why: Inadequate sanitation and contamination control in dairy processing ·
Mar 17 ·
Impact: HIGH
www.ivermectin4covid.com
Unlawful sale of unapproved drugs via internet
Why: Online sales of unapproved ivermectin products to US consumers ·
Mar 16 ·
Impact: HIGH
ALL-IN Vapors
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention Control Act ·
Mar 16 ·
Impact: HIGH
Selected medium-impact items
Stuff N Puffs 101, LLC d/b/a Stuff-N-Puffs
Tobacco products adulterated and misbranded under FSPTCA
Why: Products violated Family Smoking Prevention and Tobacco Control Act requirements ·
Mar 23 ·
Impact: MEDIUM
Marina Technology LLC
Tobacco products adulterated and misbranded under FSPTCA
Why: Products violated Family Smoking Prevention and Tobacco Control Act requirements ·
Mar 16 ·
Impact: MEDIUM
Procter & Gamble Manufactura S. de R.L. de C.V.
Failure to register and list drug products with FDA
Why: Company did not complete required FDA registration and listing procedures ·
Mar 14 ·
Impact: MEDIUM
J&H Imports Services Corp
Foreign Supplier Verification Program compliance failure
Why: Inadequate verification procedures for imported food products ·
Mar 13 ·
Impact: MEDIUM
Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC
Clinical investigator compliance violations
Why: Non-compliance with clinical investigator regulatory requirements ·
Mar 03 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →