South Birmingham Times

There were three companies in cities associated with Shelby County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% increase over the number of companies cited in the previous year.

The citations in the county include:

• Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
• 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.

Most of the companies cited were involved in the Drugs 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
Avanti Polar Lipids	Drugs	07/07/2023	Computer control of master formula records
M D I Corporation	Devices	06/15/2023	Design control - no procedures
M D I Corporation	Devices	06/15/2023	Lack of or inadequate complaint procedures
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