Sarasota Review

There were three companies in a city associated with Sarasota County that received FDA citations as a result of three inspections conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
• Procedures for training and identifying training needs have not been established.
• Document control procedures have not been adequately maintained.

Most of the companies cited were involved in the Devices sector.

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
Black Pearl Vision	Devices	04/11/2024	Documentation
Natural Immunogenics Corporation	Drugs	04/18/2024	Procedures not in writing, fully followed
Natural Immunogenics Corporation	Drugs	04/18/2024	Cleaning / Sanitizing / Maintenance
Natural Immunogenics Corporation	Drugs	04/18/2024	Absence of Written Procedures
Ziptek, LLC	Devices	05/22/2024	Lack of System for Timely Submission of Reports
Ziptek, LLC	Devices	05/22/2024	Training - Lack of or inadequate procedures
Ziptek, LLC	Devices	05/22/2024	Procedures not adequately established or maintained