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- Abiomed and Oscor advise correction of Impella catheter introducers due to leakage riskAbiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
- FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firmsThe FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…raps · 3mo agoRegulatoryNegative