Summary
High-impact items this period
Dunagin Pharmaceuticals Inc. dba Massco Dental
Finished pharmaceuticals adulterated, CGMP violations
Why: Current good manufacturing practice non-compliance in pharma ·
Feb 22 ·
Impact: HIGH
Capital Imports LLC
Foreign supplier verification program non-compliance
Why: Inadequate FSVP procedures for imported food products ·
Feb 22 ·
Impact: HIGH
Primal Pet Foods, Inc.
Animal food prepared under insanitary conditions, adulterated
Why: CGMP violations in preparation, packing, or holding processes ·
Feb 21 ·
Impact: HIGH
Gascó Industrial Corporation
CGMP violations in finished pharmaceutical manufacturing
Why: Adulteration or non-compliance with current Good Manufacturing Practices ·
Feb 17 ·
Impact: HIGH
Arrow Reliance Inc.
Animal food prepared under insanitary conditions, adulterated
Why: CGMP violations in preparation, packing, or holding processes ·
Feb 16 ·
Impact: HIGH
Frenda Corporation
Finished pharmaceuticals adulterated, CGMP violations
Why: Current good manufacturing practice non-compliance in pharma ·
Feb 15 ·
Impact: HIGH
Midlab Incorporated
Finished pharmaceuticals adulterated, CGMP violations
Why: Current good manufacturing practice non-compliance in pharma ·
Feb 15 ·
Impact: HIGH
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Adulterated finished pharmaceutical products
Why: CGMP violations in foreign pharmaceutical manufacturing facility ·
Feb 13 ·
Impact: HIGH
American Chinese Natural Herbs, Inc.
Dietary supplement CGMP violations, adulterated products
Why: Manufacturing, packaging, labeling deficiencies; product contamination ·
Feb 10 ·
Impact: HIGH
Emmons Livestock
Unapproved new animal drug products distributed
Why: Marketing animal drugs without FDA approval ·
Feb 10 ·
Impact: HIGH
Selected medium-impact items
K&D Vapors Inc
Tobacco control act violations; adulterated, misbranded products
Why: Non-compliance with smoking prevention and tobacco product regulations ·
Feb 23 ·
Impact: MEDIUM
Dotmod, Inc.
Tobacco control act violations; adulterated, misbranded products
Why: Non-compliance with smoking prevention and tobacco product regulations ·
Feb 17 ·
Impact: MEDIUM
Hastings Vapors LLC d/b/a Hastings Vapors
Tobacco control act violations; adulterated, misbranded products
Why: Non-compliance with smoking prevention and tobacco product regulations ·
Feb 16 ·
Impact: MEDIUM
The Body Bean, LLC
Failure to register and list as drug manufacturer
Why: Non-compliance with mandatory FDA registration requirements ·
Feb 06 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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