Jefferson Reporter

There was one company in a city associated with Shelby County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• The quality control unit lacks authority to fully investigate errors that have occurred.
• 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.
• Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

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
Oxford Pharmaceuticals, LLC	Drugs	11/03/2023	Authority lacking to review records, investigate errors
Oxford Pharmaceuticals, LLC	Drugs	11/03/2023	Cleaning / Sanitizing / Maintenance
Oxford Pharmaceuticals, LLC	Drugs	11/03/2023	Establishment of time limitations
Oxford Pharmaceuticals, LLC	Drugs	11/03/2023	Scientifically sound laboratory controls