# FDA 483 - Viant Medical Company - August 22, 2018

Source: https://www.globalkeysolutions.net/records/483/viant-medical-company/ef8f22b5-ee7a-4340-8ab6-afdd8987a19d

> FDA 483 for Viant Medical Company on August 22, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viant Medical Company
- Inspection Date: 2018-08-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of MedPlast Medical, Inc. in Grand Rapids, MI, a contract manufacturer and sterilizer, revealed two significant observations. The firm failed to establish adequate procedures for controlling environmental conditions in its clean room and for implementing a robust corrective and preventive action (CAPA) system, including statistical analysis of quality data. These issues indicate deficiencies in the firm's quality system.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sargum-c-sood/980cd904-0fac-488d-8ea9-39a44d8ea21d)

Company: https://www.globalkeysolutions.net/companies/viant-medical-company/fcbf7eff-1e92-4ff4-a311-fa64e4262aed

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