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Seatex LLC

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REGULATORY INTELLIGENCE·Recall

FDA Mandates Class II Recall for Seatex LLC Hand Sanitizers Over CGMP Deviations at Texas Facility

Seatex LLC has initiated a Class II recall for its PROBLEND E3 and All-In-One Foaming Hand Sanitizers following FDA inspection findings of Current Good Manufacturing Practice (CGMP) deviations at its Rosenberg, TX facility. This event underscores the critical need for robust quality systems in OTC drug manufacturing, impacting supply chain continuity and regulatory compliance for distributors and procurement teams.

90-Day Activity
Seatex LLCHand Sanitizer Spray
RMRohan Mehta· Senior Supply Chain Intelligence Analyst
2024-03-06