St. Pete Standard

There were three companies in cities associated with Pinellas County that received FDA citations as a result of three inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 40% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the requirements of 21 CFR 820.198.
• The responsibilities and procedures applicable to the quality control unit are not fully followed.

All of the companies cited should take voluntary actions to correct their managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Eagle Labs, Inc.	Drugs	12/06/2023	Written procedures not established/followed
Eagle Labs, Inc.	Drugs	12/06/2023	SOPs not followed / documented
Infinium Medical, Inc.	Devices	11/08/2023	Individual Report of Malfunction
Infinium Medical, Inc.	Devices	11/08/2023	Service reports/MDRs/complaints
Pharmetric Laboratory, LLC	Drugs	11/06/2023	Procedures not in writing, fully followed