# FDA 483 - Dextrum Laboratories Inc. - July 18, 2023

Source: https://www.keypedia.com/records/483/dextrum-laboratories-inc/8fc1f90a-29e4-4632-a905-2525bea1839e

> FDA 483 for Dextrum Laboratories Inc. on July 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dextrum Laboratories Inc.
- Inspection Date: 2023-07-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Dextrum Laboratories Inc., an OTC drug manufacturer in Miami, FL, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of validated manufacturing processes and water system re-validation, incomplete and non-contemporaneous master production records, and inadequate annual product review procedures. Additionally, the firm failed to verify component supplier analyses and lacked proper ventilation and containment systems for active pharmaceutical ingredients and organic solvents.

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## Related Officers

- [J'Maica J. Hunter](https://www.keypedia.com/people/jmaica-j-hunter/173f731f-4dc4-4ef2-8cb3-72993cb91119)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Samantha E. Cleek](https://www.keypedia.com/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)

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

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