# FDA 483 - Carwild Corporation - May 16, 2019

Source: https://www.keypedia.com/records/483/carwild-corporation/c9f98a03-8552-4d38-bf3a-e688ed3a9bba

> FDA 483 for Carwild Corporation on May 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carwild Corporation
- Inspection Date: 2019-05-16
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Caraid Corporation in New London, CT, a specification developer, was inspected by the FDA from May 13-16, 2019. The inspection revealed significant deficiencies in design control processes for their Ivalon PVA ophthalmic sponges. Specifically, the firm failed to review, update, and approve design plans as development evolved, and did not adequately establish procedures for design transfer.

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/carwild-corporation/100cc610-da72-4b8c-a3c3-9d51cb2719bc

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94