FDA WARNING_LETTER - Magnolia Medical Technologies, Inc. - July 15, 2021

The FDA issued a Warning Letter to a medical device firm following an inspection from June 3, 2021, to July 15, 2021. The firm, a specification developer for the Steripath Gen 2 Blood Collection System (K192247), was found to have adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation, 21 CFR Part 820.

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: * Meeting minutes for CAPA activities (CAR C00046) were not documented or attached as required by SOP D00011, Rev. D. The firm's response was inadequate as it did not finalize minutes or evaluate other CARs for similar deficiencies. * Inadequate investigation of potential causes for premature retraction of butterfly needles in CAR C00046. The firm failed to document evaluations of all identified causes. * CAR C00050, concerning incorrect IFU designations, did not adequately investigate and correct all affected products, including a distributed lot (9448037). * CAR C00055, regarding un-