MicroVention located in Costa Rica was issued a warning letter from the FDA for reason “that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.” More specific examples include, “failure to verify a process that cannot be fully verified by subsequent inspection and test with a high degree of assurance and approved according to established procedures, do not specify the requirements for the catheter wash process validation prior to conducting the process validation, and a gap analysis and selection of biological endpoints for assessment is necessary to assess the biological safety of the medical device.” For more information, see the link below.
