Indy Standard

There was one company in a city associated with Marion 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 a 50% decrease from the number of companies cited in the previous month.

The citations in the county include:

• Your quality control operations did not include periodically reviewing all records for calibration of instruments and controls.
• Your batch production records did not include documentation that quality control personnel reviewed the batch production record.
• You held components and dietary supplements under conditions that lead to mix-up, contamination, or deterioration.

The company cited should take a voluntary action to correct its 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
Vesta Pharmaceuticals, Inc.	Food and Cosmetics	02/09/2024	Quality control operations - calibration records
Vesta Pharmaceuticals, Inc.	Food and Cosmetics	02/09/2024	Batch record - quality control review; production
Vesta Pharmaceuticals, Inc.	Food and Cosmetics	02/09/2024	Hold - mix-up, contamination, deterioration