# FDA 483 - PRIVATE LABEL PRODUCTIONS LLC - February 09, 2024

Source: https://www.keypedia.com/records/483/private-label-productions-llc/ca1f28d5-3e7b-4b1b-8806-12ec6e020c04

> FDA 483 for PRIVATE LABEL PRODUCTIONS LLC on February 09, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PRIVATE LABEL PRODUCTIONS LLC
- Inspection Date: 2024-02-09
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: PRIVATE LABEL PRODUCTIONS LLC, a manufacturer in Bonita Springs, FL, received two observations during an FDA inspection from February 6-9, 2024. The firm was cited for failing to conduct management review meetings and internal quality audits at defined intervals as established in their own procedures. These observations indicate deficiencies in the firm's quality system oversight and self-assessment processes.

## Related Officers

- [Nydia E. Colon](https://www.keypedia.com/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.keypedia.com/companies/private-label-productions-llc/3490877b-96b1-45b2-a7ee-158058414d45

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