Tampa Republic

There was one company in a city associated with Hillsborough County that received FDA citations as a result of one inspection conducted in the county in February, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.

The company cited had to take regulatory and/or administrative actions.

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
LiquidCapsule Manufacturing, LLC	Drugs	02/09/2024	Procedures not in writing, fully followed
LiquidCapsule Manufacturing, LLC	Drugs	02/09/2024	Absence of Written Procedures
LiquidCapsule Manufacturing, LLC	Drugs	02/09/2024	Procedures for non-sterile drug products
LiquidCapsule Manufacturing, LLC	Drugs	02/09/2024	Expiration date lacking
LiquidCapsule Manufacturing, LLC	Drugs	02/09/2024	Acceptance criteria for sampling & testing