# FDA 483 - Toaster Labs, Inc. - April 04, 2023

Source: https://www.keypedia.com/records/483/toaster-labs-inc/cb40cdf3-168a-4a2b-9ac5-e6500cf8ff80

> FDA 483 for Toaster Labs, Inc. on April 04, 2023. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Toaster Labs, Inc.
- Inspection Date: 2023-04-04
- Product Type: devices
- Office Name: Seattle District Office
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) on April 3-4, 2023, Toaster Labs, Inc., a medical device manufacturer, received a Form FDA 483 outlining three significant observations. These findings indicate a need for improved adherence to quality system requirements crucial for ensuring the safety and efficacy of their products, which include Class 2 personal lubricants. 

The FDA identified deficiencies in the company's Medical Device Reporting (MDR) procedures. The internal system for evaluating events that may require MDR was deemed inadequate, with multiple complaints involving adverse effects like scabbing, bleeding, bladder infections, and skin rashes not being properly or timely assessed. The MDR decision tree, a key component, was often incomplete or inaccurately documented. 

Additionally, Toaster Labs, Inc. lacked adequately established Corrective and Preventive Action (CAPA) procedures. A specific CAPA was significantly delayed, and extension requests were not managed promptly according to internal protocols. The inspection also revealed insufficient procedures for ensuring purchased products and services conform to specified requirements. The company could not provide evidence of required performance reviews for key suppliers, including their contract manufacturer and packaging manufacturer, with documentation gaps extending back to 2017. 

These observations highlight the necessity for Toaster Labs, Inc. to enhance its quality management system to comply with medical device regulations. The company has acknowledged these issues and committed to implementing corrective actions to address each finding.

## Related Documents

- [483 - 2023-04-04](https://www.keypedia.com/records/483/toaster-labs-inc/67315b36-9e9c-4a4b-9518-97693fd3e112)

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/toaster-labs-inc/e4b501de-0ef6-4fd8-aebf-f8a6c89e9eac

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913