REGULATORY INTELLIGENCE·Warning Letter
Golden State Medical Supply's Aripiprazole Recall: Dissolution Failures Expose Quality Control Gaps
Golden State Medical Supply Inc. initiated a Class II nationwide recall of 11,922 bottles of Aripiprazole Tablets, 15 mg, due to failed dissolution specifications. This event, stemming from a critical quality control lapse, underscores the imperative for robust supplier qualification and stringent in-process testing for pharmaceutical packagers. Procurement and regulatory teams must reassess their due diligence protocols to mitigate similar supply chain risks.
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