# FDA 483 - Dextrum Laboratories Inc. - August 29, 2024

Source: https://www.globalkeysolutions.net/records/483/dextrum-laboratories-inc/5fefa31f-4e30-423d-8aef-04db7c079282

> FDA 483 for Dextrum Laboratories Inc. on August 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dextrum Laboratories Inc.
- Inspection Date: 2024-08-29
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Dextrum Laboratories Inc., an OTC liquid drug product manufacturer in Miami, revealed significant deficiencies in their quality systems and manufacturing processes. Observations included failures in maintaining a validated water system, inadequate component testing for high-risk materials, and a lack of proper stability testing facilities. The firm also demonstrated widespread issues with documentation, quality control unit procedures, incomplete process validations, and insufficient measures to prevent microbiological contamination.

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## Related Officers

- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [J'Maica J. Hunter](https://www.globalkeysolutions.net/people/jmaica-j-hunter/173f731f-4dc4-4ef2-8cb3-72993cb91119)

Company: https://www.globalkeysolutions.net/companies/dextrum-laboratories-inc/1de70261-362f-45f3-b0d3-19292a4eb0f4

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