# FDA 483 - Ultrum Labs LLC - October 16, 2023

Source: https://www.keypedia.com/records/483/ultrum-labs-llc/452e3c27-73d5-4c78-98b1-df19d586b29c

> FDA 483 for Ultrum Labs LLC on October 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultrum Labs LLC
- Inspection Date: 2023-10-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ultrum Labs LLC, an OTC drug manufacturer in Tampa, FL, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across quality control, data integrity, production procedures, and equipment cleaning. Key issues included inadequate raw material testing and release, failure to follow written procedures, lack of computer system controls, and absence of critical validation studies.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)

Company: https://www.keypedia.com/companies/ultrum-labs-llc/55b122bd-b18f-429a-99fa-991470ec9e90

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