Summary
High-impact items this period
Coombe Castle International Ltd.
Low acid canned food adulterated
Why: Failure to comply with low acid canned food regulations ·
Mar 29 ·
Impact: HIGH
Central Admixture Pharmacy Services, Inc.
Drug products adulterated via CGMP violations
Why: Current good manufacturing practice violations in drug production ·
Mar 29 ·
Impact: HIGH
Kilitch Healthcare India Limited
Finished pharmaceutical products adulterated
Why: CGMP non-compliance in pharmaceutical manufacturing ·
Mar 28 ·
Impact: HIGH
Vintage Chemical Inc.
Finished pharmaceutical products adulterated
Why: Current good manufacturing practice violations in pharma production ·
Mar 27 ·
Impact: HIGH
Bodywell Natural Skin Care Inc.
Finished pharmaceuticals adulterated, unapproved new drug
Why: CGMP violations and marketing without FDA approval ·
Mar 27 ·
Impact: HIGH
TKTX Company
Unapproved pharmaceutical marketed without FDA approval
Why: Lack of premarket approval for topical pharmaceutical product ·
Mar 25 ·
Impact: HIGH
Central Admixture Pharmacy Services, Inc.
Drug products adulterated via CGMP violations
Why: Current good manufacturing practice violations in drug production ·
Mar 25 ·
Impact: HIGH
Indelicare DBA INKEEZE
Unapproved pharmaceutical marketed without FDA approval
Why: Lack of premarket approval for topical pharmaceutical product ·
Mar 25 ·
Impact: HIGH
Sky Bank Media, LLC dba Painless Tattoo Cream Co.
Unapproved pharmaceutical marketed without FDA approval
Why: Lack of premarket approval for topical pharmaceutical product ·
Mar 25 ·
Impact: HIGH
Tattoo Numbing Cream Co.
Unapproved pharmaceutical marketed without FDA approval
Why: Lack of premarket approval for topical pharmaceutical product ·
Mar 25 ·
Impact: HIGH
Selected medium-impact items
Juquilita Mexican Imports LLC
Foreign supplier verification program compliance failures
Why: Insufficient FSVP documentation and supplier monitoring processes ·
Mar 25 ·
Impact: MEDIUM
Wagco Distribution, Inc.
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Mar 21 ·
Impact: MEDIUM
Bret R. Rutherford, M.D.
Clinical investigator regulatory non-compliance
Why: Deficiencies in conduct of clinical research or IND protocols ·
Mar 21 ·
Impact: MEDIUM
New York State Psychiatric Institute IRB
Institutional Review Board regulatory deficiencies
Why: IRB protocol review and oversight non-compliance ·
Mar 21 ·
Impact: MEDIUM
Augustine Temperature Management, LLC
Medical device reporting and misbranding violations
Why: Failure to properly report adverse events and misleading labeling ·
Mar 21 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →