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FDA Enforcement — November 2022 Report

Automated analysis of 69 items from public government data sources. Updated daily.

Summary

69
Total items
33
High impact
36
Medium impact
0
Low impact

High-impact items this period

Kari Gran Inc.
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice violations in pharmaceutical production  ·  Nov 30  ·  Impact: HIGH
Gobwa Exotic Imports Inc.
Foreign supplier verification program non-compliance
Why: Failure to verify foreign food supplier safety standards  ·  Nov 29  ·  Impact: HIGH
Mike Millenkamp Dairy Cattle
Adulterated animal drug products distributed
Why: Use of unapproved new animal drugs in dairy operations  ·  Nov 28  ·  Impact: HIGH
AG Hair Limited
CGMP violations in finished pharmaceutical manufacturing
Why: Drug product adulteration or manufacturing deficiencies  ·  Nov 28  ·  Impact: HIGH
Bainbridge Beverage West, LLC
Juice manufacturing HACCP and insanitary conditions violations
Why: Failure to implement adequate food safety controls and sanitation  ·  Nov 28  ·  Impact: HIGH
Cecilia Alvarez
Foreign supplier verification program non-compliance
Why: Failure to verify foreign food supplier safety standards  ·  Nov 22  ·  Impact: HIGH
Florida Gold Foods LLC
Food prepared under insanitary conditions adulteration
Why: Manufacturing facility sanitation and food safety control failures  ·  Nov 22  ·  Impact: HIGH
Glenmark Pharmaceuticals Limited
CGMP violations in finished pharmaceutical manufacturing
Why: Quality control or manufacturing process deficiencies in drug products  ·  Nov 22  ·  Impact: HIGH
Euphoria Fancy Food Inc.
Foreign supplier verification program non-compliance
Why: Failure to verify foreign food supplier safety standards  ·  Nov 21  ·  Impact: HIGH
"David M. Lubeck, M.D./Arbor Centers for EyeCare
Clinical investigator protocol deviations
Why: Non-compliance with clinical trial regulations or sponsor requirements  ·  Nov 18  ·  Impact: HIGH

Selected medium-impact items

Jayde's Vapor Lounge
Tobacco Control Act violation - adulterated/misbranded products
Why: Non-compliant tobacco product distribution or marketing  ·  Nov 30  ·  Impact: MEDIUM
CHS Inc./CHS River Plains
CGMP violations in medicated animal feed manufacturing
Why: Adulterated medicated feeds from inadequate manufacturing controls  ·  Nov 30  ·  Impact: MEDIUM
Aspire Pharmaceuticals, Inc.
CGMP violations in dietary supplement manufacturing and labeling
Why: Manufacturing deficiencies in supplement production and packaging operations  ·  Nov 22  ·  Impact: MEDIUM
Nature’s Way Farms, LLC
Failed Foreign Supplier Verification Program compliance
Why: Inadequate verification procedures for imported food ingredients  ·  Nov 21  ·  Impact: MEDIUM
Shenzhen Fumot Technology Co., Ltd.
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Nov 16  ·  Impact: MEDIUM

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Data sourced from public government APIs. AI analysis via Claude Haiku. Full methodology →