Sarasota Review

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

This is a 100% increase over the number of companies cited in the previous month.

The citations in the county include:

• Corrective and preventive action activities and/or results have not been adequately documented.
• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Both 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