# FDA 483 - QOL Medical LLC - January 09, 2026

Source: https://www.keypedia.com/records/483/qol-medical-llc/dfae852a-3a0a-412a-923d-4a813dc82572

> FDA 483 for QOL Medical LLC on January 09, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QOL Medical LLC
- Inspection Date: 2026-01-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: QOL Medical, LLC in Clearwater, FL, a drug substance manufacturer, was cited for significant deficiencies across its manufacturing and quality systems. The inspection revealed inadequate process validation, poor contamination control, lack of quality oversight, and issues with electronic data systems and laboratory controls. These findings indicate a systemic failure to ensure the quality, purity, and safety of their drug products.

## Related Documents

- [EIR - 2019-08-30](https://www.keypedia.com/records/eir/qol-medical-llc/f2a475f5-7b54-4934-a330-98191631c975)
- [483 - 2019-08-27](https://www.keypedia.com/records/483/qol-medical-llc/e2471b17-3b03-47e9-842b-38f1de297262)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Regulatory Scientist at FDA](https://www.keypedia.com/people/yi-wang/f5355ae0-ae28-452f-829a-786b7ebc4791)
- [issuing_officer](https://www.keypedia.com/people/jee-y-chung/0736677f-9719-44dc-9dab-60b610ac1a0a)

Company: https://www.keypedia.com/companies/qol-medical-llc/83e2d372-ec27-4388-ab26-9774d5edcc55

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