# FDA 483 - Pacific Consolidated Industries LLC - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/pacific-consolidated-industries-llc/06922644-e6da-4774-aa43-a8f28a8a8efd

> FDA 483 for Pacific Consolidated Industries LLC on July 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacific Consolidated Industries LLC
- Inspection Date: 2025-07-25
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Pacific Consolidated Industries LLC in Riverside, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established and implemented, with issues in classification, timely completion, and record-keeping. Additionally, procedures for design change were insufficient, lacking proper justification, risk assessments, verification, and validation for engineering changes, and inconsistent use of a 510(k) decision flow chart.

## Related Documents

- [483 - 2021-10-28](https://www.globalkeysolutions.net/records/483/pacific-consolidated-industries-llc/71cca904-2a96-4ef1-bf20-dd58e4fe5b57)

## Related Officers

- [Linda Galindo](https://www.globalkeysolutions.net/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.globalkeysolutions.net/companies/pacific-consolidated-industries-llc/5319bad9-5610-41da-85a4-b92881a64d8b

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