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MicroVention Costa Rica S.R.L. was cited for manufacturing medical devices (Headway Microcatheter, LVIS, LVIS Jr, Scepter C and XC Occlusion Balloon Catheter, SOFIA Catheters, and BOBBY Balloon Guide Catheter) in violation of current good manufacturing practice requirements under 21 CFR Part 820. The primary violation identified was failure to properly validate manufacturing processes that cannot be fully verified by subsequent inspection and testing, including inadequate documentation of validation activities, approval signatures, and major equipment validated. The FDA conducted an inspection of the Costa Rica facility from May 23-26, 2022, and the company submitted responses to the inspectional observations between June and August 2022, but compliance gaps remained unresolved.