Regulatory Enforcement Action

Inside PharMEDium’s Consent Decree: What the Terms Reveal About FDA’s Enforcement Standard and the Manufacturing System It Will Accept

Khaled A. Aamer, Ph.D.

Revisiting the 2019 PharMEDium Services consent decree as a teaching case: the clearest available precedent for how a 503B outsourcing facility’s aseptic processing failures escalate to FDA’s most severe civil enforcement tool short of seizure.

Babikian Healthcare Products Added to Import Alert 66-40: The CGMP Pattern Behind the Detention and What Every Quality Director Managing Dietary Supplement and OTC Drug Sites Must Know

Khaled A. Aamer, Ph.D.

FDA added Babikian Healthcare Products to Import Alert 66-40 with a blanket Detention Without Physical Examination across its entire drug product line — with no companion Warning Letter publicly available to explain the underlying finding.

CareFusion 213, LLC (BD) Class I Recall — ChloraPrep Sterile Antiseptic Applicators: The Sterile Manufacturing System Failure Behind the Recall and What Every Aseptic Processing Director Must Address

Khaled A. Aamer, Ph.D.

A Class I recall of BD ChloraPrep sterile antiseptic applicators for non-sterility and a packaging-seal defect follows an April 2026 Warning Letter at the same El Paso, TX facility citing the identical failure pair.

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