# FDA 483 - QOL Medical LLC - August 27, 2019

Source: https://www.keypedia.com/records/483/qol-medical-llc/e2471b17-3b03-47e9-842b-38f1de297262

> FDA 483 for QOL Medical LLC on August 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QOL Medical LLC
- Inspection Date: 2019-08-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations Central
- Summary: An FDA inspection of QOL Medical, LLC in Clearwater, FL, a drug substance manufacturer, revealed a significant issue concerning the firm's equipment management. The company failed to properly execute and document its preventive maintenance program, specifically regarding the calibration of critical equipment used in the manufacturing of Sacrosidase Drug Substance. This indicates a deficiency in maintaining equipment in a state of control.

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

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-operations-central/fdd6d0ca-6039-4ac5-8989-2b0514b056f0