# FDA 483 - C&W Swiss Inc - April 12, 2019

Source: https://www.keypedia.com/records/483/cw-swiss-inc/43007490-3099-46e2-a51c-5926c9beadc2

> FDA 483 for C&W Swiss Inc on April 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C&W Swiss Inc
- Inspection Date: 2019-04-12
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: C&W Swiss Inc, a medical device manufacturer in Englewood, OH, received a Form FDA-483 with four observations. The inspection revealed significant deficiencies in their quality system, including unvalidated manufacturing processes, inadequate corrective and preventive action procedures, insufficient supplier evaluation, and a lack of written Medical Device Reporting procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.keypedia.com/companies/cw-swiss-inc/46a32532-46d6-4dda-83f6-9fa9dac03cee

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22