# FDA 483 - Dot America, Inc. - June 14, 2021

Source: https://www.keypedia.com/records/483/dot-america-inc/bb9ee395-be33-4215-85fd-ab0d545c7168

> FDA 483 for Dot America, Inc. on June 14, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dot America, Inc.
- Inspection Date: 2021-06-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Dot America, Inc. in Columbia City, IN, revealed significant deficiencies in process validation and acceptance activities. The firm failed to adequately validate processes and software, including issues with testing, documentation, and acceptance criteria. Additionally, procedures for accepting nonconforming products were not properly established, leading to defects being accepted without documented customer notification.

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/dot-america-inc/e6803b7f-0032-412d-a621-170ccae42870

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