# FDA 483 - GLOBAL WIDGET LLC - November 17, 2023

Source: https://www.globalkeysolutions.net/records/483/global-widget-llc/b3ba67b2-13c3-4911-8f30-8e424c80b1f7

> FDA 483 for GLOBAL WIDGET LLC on November 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLOBAL WIDGET LLC
- Inspection Date: 2023-11-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: GLOBAL WIDGET LLC, a drug manufacturer in Tampa, FL, was cited for significant deficiencies in its quality control and production systems during an FDA inspection. Observations included inadequate raw material and finished product testing, a non-compliant quality unit lacking written procedures and oversight, and a failure to establish proper production and process controls, including process validation and equipment qualification. These issues raise concerns about the identity, strength, purity, and quality of their OTC drug products.

## Related Officers

- [Suzanne N. Vallez](https://www.globalkeysolutions.net/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)

Company: https://www.globalkeysolutions.net/companies/global-widget-llc/607913cb-a6a9-45c1-ad63-627e0860cce4

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