# FDA 483 - Serim Research Corporation - July 30, 2025

Source: https://www.globalkeysolutions.net/records/483/serim-research-corporation/fa2486d6-7d10-4677-ac1c-03ea06545676

> FDA 483 for Serim Research Corporation on July 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Serim Research Corporation
- Inspection Date: 2025-07-30
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Serim Research Corporation in Elkhart, IN, a medical device manufacturer, revealed significant deficiencies in its quality management system. The firm was cited for inadequate risk analysis, statistically unsound sampling plans for finished goods, and a lack of established procedures for equipment calibration and maintenance. Additionally, the company failed to adequately address underperforming suppliers according to its own procedures.

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/serim-research-corporation/43cbb42f-27ff-44dc-8d99-84bf444eb5a1

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