Summary
High-impact items this period
Baits and Sea Foods, S.A.
Seafood adulterated under insanitary conditions
Why: Failed HACCP and CGMP requirements in seafood processing ·
Jun 30 ·
Impact: HIGH
Amor Nino Foods, Inc.
Seafood HACCP/CGMP violation, insanitary conditions, adulterated
Why: Failure to implement hazard analysis controls and sanitary practices ·
Jun 26 ·
Impact: HIGH
Lone Pine Farm
Shell eggs produced under adulterated conditions
Why: Violation of PHS Act and shell egg regulation requirements ·
Jun 26 ·
Impact: HIGH
Suprimo Imports
Unapproved new drugs imported and misbranded
Why: Marketing unapproved drug products without required FDA approval ·
Jun 22 ·
Impact: HIGH
Five Leaf Pet Botanicals, Inc.
Unapproved new animal drug products distributed
Why: Marketing animal drugs without premarket FDA approval ·
Jun 22 ·
Impact: HIGH
Porfirios Italian Foods, Inc.
Food product prepared under insanitary conditions adulterated
Why: CGMP violations in food preparation and handling practices ·
Jun 21 ·
Impact: HIGH
Chengdu KeCheng Fine Chemicals Co., Ltd.
Active pharmaceutical ingredient adulterated
Why: CGMP violations in API manufacturing and quality control ·
Jun 20 ·
Impact: HIGH
Healthtex Distributors, Inc.
CGMP violations in dietary supplement manufacturing operations
Why: Facility failed good manufacturing practice standards for dietary supplements ·
Jun 15 ·
Impact: HIGH
Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd.
Clinical investigator protocol violations
Why: Sponsor non-compliance with FDA clinical investigation regulations and reporting requirements ·
Jun 14 ·
Impact: HIGH
Cheshni Foods LLC
Foreign supplier verification program non-compliance
Why: Failure to implement adequate supplier verification procedures ·
Jun 14 ·
Impact: HIGH
Selected medium-impact items
Vapor Salon
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 29 ·
Impact: MEDIUM
Everything Vapor Aztec
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 29 ·
Impact: MEDIUM
A Perfect Vape, LLC
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 22 ·
Impact: MEDIUM
United Zone Store
Tobacco product adulteration and misbranding violations
Why: Non-compliance with FSPTCA requirements for labeling and product standards ·
Jun 16 ·
Impact: MEDIUM
Mr-Joy Group Holding B.V. d/b/a Mr. Joy
Tobacco product adulteration and misbranding violations
Why: Non-compliance with FSPTCA requirements for labeling and product standards ·
Jun 16 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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