Gloucester Today

There were three companies in cities associated with Gloucester 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:

• Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor was deferred or determined not to be eligible for donation.
• The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Reserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.

All of the companies cited were involved in either Biologics, Drugs, or Food and Cosmetics 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
ABO Plasma Glassboro, LLC	Biologics	03/14/2023	Notification w/in 8 weeks
Berat Corporation	Food and Cosmetics	10/27/2023	HACCP plan implementation
Berat Corporation	Food and Cosmetics	10/27/2023	Food safety hazards
Berat Corporation	Food and Cosmetics	10/27/2023	Monitoring - adequacy
Berat Corporation	Food and Cosmetics	10/27/2023	Records values/observations
Berat Corporation	Food and Cosmetics	10/27/2023	Corrective action documentation
Berat Corporation	Food and Cosmetics	10/27/2023	Verification - record review - frequency
Keystone Industires	Drugs	07/20/2023	Procedures not in writing, fully followed
Keystone Industires	Drugs	07/20/2023	Reserve samples identified, representative, stored
Keystone Industires	Drugs	07/20/2023	Theoretical yield statement including percentages