# FDA 483 - Pedia Parents Inc. DBA Pedia Pals - April 24, 2025

Source: https://www.keypedia.com/records/483/pedia-parents-inc-dba-pedia-pals/cf2dc82c-3c67-45de-bc0d-eca5a8fe22c1

> FDA 483 for Pedia Parents Inc. DBA Pedia Pals on April 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pedia Parents Inc. DBA Pedia Pals
- Inspection Date: 2025-04-24
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Pedia Parents Inc. DBA Pedia Pals, a medical device specification developer in Buffalo, NY, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, management reviews, and design reviews. These issues indicate a lack of robust quality system controls for medical device development.

## Related Documents

- [483 - 2022-07-14](https://www.keypedia.com/records/483/pedia-parents-inc-dba-pedia-pals/dd2e9eaa-380c-4ab6-ba6c-d01fd2dff62a)

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/pedia-parents-inc-dba-pedia-pals/a34ad915-8e33-4faa-aa7a-db72caead9bf

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d
