Loading…
Magnolia Medical Technologies received a warning letter for adulteration of the Steripath Gen 2 Blood Collection System, a medical device used in blood collection and diagnostics. FDA inspectors found that the company failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820, specifically identifying failures to establish and maintain adequate procedures for corrective and preventive action (CAPA) as required by 21 CFR 820.100(a). The inspection, conducted from June through July 2021, determined that the device's manufacturing, packing, storage, and installation methods did not meet quality system regulation standards. The company had submitted a response to the initial FDA 483 observations on August 5, 2021, but the violations were not deemed adequately addressed.