# FDA 483 - Pompano Precision Products, Inc. - April 24, 2019

Source: https://www.globalkeysolutions.net/records/483/pompano-precision-products-inc/29e3e197-ffcf-49fb-860e-47757407d97a

> FDA 483 for Pompano Precision Products, Inc. on April 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pompano Precision Products, Inc.
- Inspection Date: 2019-04-24
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pompano Precision Products, Inc. in Pompano Beach, FL, a contract manufacturer, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in their quality system, including unvalidated software and processes, inadequate statistical techniques for sampling, insufficient control over nonconforming products, and deficient corrective and preventive action procedures. Additionally, complaint investigation records lacked essential information.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/pompano-precision-products-inc/4777ba48-aabb-413c-a15f-9738314cd64e

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