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

Source: https://www.globalkeysolutions.net/records/483/richard-allan-scientific-company/276e8781-f3cb-44b2-9146-a234fdf97c8f

> FDA 483 for Richard-Allan Scientific Company on April 23, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richard-Allan Scientific Company
- Inspection Date: 2025-04-23
- Product Type: other
- Office Name: Detroit District Office
- Summary: 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.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/richard-allan-scientific-company/8cf384b4-5161-4f3a-9ffe-853b28ac7933

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03