483
LGM Pharma Solutions, LLCFDA 483 - LGM Pharma Solutions, LLC - March 01, 2024
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LGM Pharma Solutions, LLC in Irvine, CA, received a Form FDA 483 with four observations following an inspection from February 21 to March 1, 2024. The inspection revealed significant deficiencies in the firm's quality control unit procedures, production and process controls, laboratory data integrity, and equipment cleaning and maintenance. These issues indicate a lack of adequate controls to ensure drug product quality and purity.
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