# FDA 483 - PROVISIO MEDICAL INC - February 27, 2026

Source: https://www.keypedia.com/records/483/provisio-medical-inc/ed4bbf06-358a-411b-8333-d54a4d569b14

> FDA 483 for PROVISIO MEDICAL INC on February 27, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PROVISIO MEDICAL INC
- Inspection Date: 2026-02-27
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: PROVISIO MEDICAL INC, a medical device manufacturer in San Diego, CA, was cited for significant deficiencies during an FDA inspection. Observations included failures to adequately address nonconforming catheters, implement proper design change controls, and ensure effective corrective actions to prevent recurrence of issues. These findings suggest a breakdown in the firm's quality management system.

## Related Officers

- [Jenny L. Chisem](https://www.keypedia.com/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.keypedia.com/companies/provisio-medical-inc/1deaef86-8dc5-45f8-a73f-3241331ce61a

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b