483
Richard-Allan Scientific CompanyRichard-Allan Scientific Company – FDA 483, Apr 23, 2025
Record Details
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.
View Company Profile
ID · 276e8781-f3cb-44b2-9146-a234fdf97c8f
Other documents for Richard-Allan Scientific Company
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.