FDA 483 - Richard-Allan Scientific Company - April 23, 2025

Richard-Allan Scientific Company in Kalamazoo, MI, was cited for three significant issues during an FDA inspection. Observations included a failure to report a serious medical device malfunction, inadequate revalidation of a deionized water process after a change, and statistically unsound sampling plans for product fill volume verification. These issues indicate deficiencies in quality system controls that could impact product safety and quality.