# Serim Research Corporation – FDA 483, Apr 7, 2022

Source: https://www.keypedia.com/records/483/serim-research-corporation/806332cd-09a5-4e83-b42c-36e788c151f8

> FDA 483 for Serim Research Corporation on April 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Serim Research Corporation
- Inspection Date: 2022-04-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Serim Research Corporation in Elkhart, IN, a medical device manufacturer, was inspected by the FDA. The inspection revealed one significant observation concerning the firm's device history records. Specifically, manufacturing records for Serim PeriScreen Test Strips did not align with the device master record, as material usage was outside established validated ranges.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0