# FDA 483 - Pan Medical U.S. Corp - March 05, 2020

Source: https://www.globalkeysolutions.net/records/483/pan-medical-us-corp/ac0dc2f1-649a-4147-8ef2-e3fa1b000fd2

> FDA 483 for Pan Medical U.S. Corp on March 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pan Medical U.S. Corp
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pan Medical U.S. Corp in Largo, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate corrective and preventive action procedures, failure to implement effective Medical Device Reporting procedures resulting in late submissions, and insufficient validation of critical manufacturing processes. Additionally, environmental control procedures for their cleanroom were found to be lacking defined limits.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.globalkeysolutions.net/companies/pan-medical-us-corp/6ac51a54-5adc-4a63-b2a9-6ca8a2476238

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