Jefferson Reporter

There were three companies in cities associated with Jefferson 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 25% decrease from the number of companies cited in the previous year.

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.

All of the companies cited were involved in either Drugs, Devices, or Biologics sectors.

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
Alabama Fertility Specialists, PC	Biologics	03/15/2023	Design of procedures to ensure compliance
Alabama Fertility Specialists, PC	Biologics	03/15/2023	Statement re: certified testing lab
Alabama Fertility Specialists, PC	Biologics	03/15/2023	SOP for release; reactive for CMV
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