How many companies in cities across Shelby County received FDA citations in Q2?

James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

By K. L. Willingham

Jul 21, 2025

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 second quarter of 2025, 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 quarter.

The citations in the county include:

The responsibilities and procedures applicable to the quality control unit are not in writing.
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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 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.

According to its website, 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.

Companies located within Shelby County Cities and the citations they received in Q2

Company Name	Area of Business	Inspection Date	Issue Cited
Playtex Manufacturing - Plant #2, Inc.	Drugs	04/07/2025	Procedures not in writing, fully followed
Playtex Manufacturing - Plant #2, Inc.	Drugs	04/07/2025	Written procedures not established/followed
Playtex Manufacturing - Plant #2, Inc.	Drugs	04/07/2025	Computer control of master formula records
Playtex Manufacturing - Plant #2, Inc.	Drugs	04/07/2025	Control procedures to monitor and validate performance
Playtex Manufacturing - Plant #2, Inc.	Drugs	04/07/2025	Scientifically sound laboratory controls
Playtex Manufacturing - Plant #2, Inc.	Drugs	04/07/2025	Investigations of discrepancies, failures