# PB&M BRANDS, LLC – FDA 483, Mar 8, 2022

Source: https://www.keypedia.com/records/483/pbm-brands-llc/494b4243-92da-41d5-b017-ab6a007f2fbe

> FDA 483 for PB&M BRANDS, LLC on March 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PB&M BRANDS, LLC
- Inspection Date: 2022-03-08
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: PB&M BRANDS, LLC, a medical device importer in Sarasota, FL, received a Form FDA-483 with five observations during an inspection. The firm was cited for a complete lack of established quality system procedures, including those for quality policy, corrective and preventive actions, complaint handling, medical device reporting, and purchasing controls for examination gloves. These deficiencies indicate significant gaps in their quality management system for imported medical devices.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/pbm-brands-llc/0f739e13-a395-4d82-bb8a-a5b21c14143a

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