# FDA 483 - Pedicraft, Inc. - July 25, 2025

Source: https://www.keypedia.com/records/483/pedicraft-inc/ebcf6cef-37b6-4c63-815f-f14be00cb9c0

> FDA 483 for Pedicraft, Inc. on July 25, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pedicraft, Inc.
- Inspection Date: 2025-07-25
- Product Type: other
- Office Name: Florida District Office
- Summary: Pedicraft, Inc. in Jacksonville, FL, was inspected by the FDA from July 22-25, 2025, revealing two significant repeat observations. The firm failed to adequately establish procedures for corrective and preventive action, neglecting to open CAPAs for previous inspection findings. Additionally, individuals conducting quality audits had direct responsibility for the matters being audited, contrary to their own updated procedures.

## Related Documents

- [483 - 2020-01-17](https://www.keypedia.com/records/483/pedicraft-inc/6e8fab6e-c663-4a15-bebb-c846af072283)

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9