Richard-Allan Scientific CompanyApril 23, 2025

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

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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.

Company: Richard-Allan Scientific Company
Inspection Date: April 23, 2025
Product Type: Other
Office: Detroit District Office
Person: Suyang Qin ( Investigator )

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ID · 276e8781-f3cb-44b2-9146-a234fdf97c8f