# FDA 483 - Vesta Inc. - October 20, 2017

Source: https://www.keypedia.com/records/483/vesta-inc/6bc1cba3-4bf6-4a39-ad03-3fe5bb3dc991

> FDA 483 for Vesta Inc. on October 20, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vesta Inc.
- Inspection Date: 2017-10-20
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: During an inspection, medical device manufacturer VESTA in Franklin, WI, was cited for significant deficiencies in process validation for its sterilizers, including failure to follow established protocols and a lack of objective evidence for critical steps. Additionally, the firm lacked adequate procedures for preventing contamination, specifically concerning environmental monitoring frequency and clean room sampling. These issues indicate a failure to ensure product quality and adherence to quality system requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/vesta-inc/3ae5130d-4835-46fb-b93c-4f1c1e59c18e

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d