# FDA 483 - Pedicraft, Inc. - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/pedicraft-inc/6e8fab6e-c663-4a15-bebb-c846af072283

> FDA 483 for Pedicraft, Inc. on January 17, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pedicraft, Inc.
- Inspection Date: 2020-01-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pedicraft, Inc., a medical device manufacturer in Jacksonville, FL, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found that risk analysis for Class II bassinets and cribs was incomplete and did not cover all foreseeable risks. Additionally, the firm's procedures for corrective and preventive actions and quality audits were deemed inadequately established.

## Related Documents

- [483 - 2025-07-25](https://www.globalkeysolutions.net/records/483/pedicraft-inc/ebcf6cef-37b6-4c63-815f-f14be00cb9c0)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)

Company: https://www.globalkeysolutions.net/companies/pedicraft-inc/348fce14-ecf0-487a-9b55-1d1d07357e2a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6