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Talk to a SpecialistTalk to a SpecialistMarcus Research Laboratory, Inc. was cited for significant deviations from current good manufacturing practice (CGMP) in the production of povidone iodine (PVP-I) active pharmaceutical ingredients used in presurgical preparatory products. The company failed to establish adequate procedures and processes to ensure API met established quality and purity specifications, particularly after critical incidents such as a March 2020 smoldering event in a reactor cabinet where fire extinguisher use compromised normal production conditions and exposed material to inconsistent temperatures and extended hold times. Despite these deviations, the Quality Unit released affected lots (100017872R and 100017911C) for further processing after only limited testing for available iodine content, without conducting thorough investigations or implementing corrective actions to ensure product safety and quality.