South Bend Times

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

This is a 66.7% increase over the number of companies cited in the previous year.

Of the 13 citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.

Most of the companies cited were involved in either Devices 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
BBS Enterprises	Devices	04/12/2023	Process control procedures, Lack of or inadequate procedures
BBS Enterprises	Devices	04/12/2023	Lack of or inadequate complaint procedures
Macri Italian Bakery	Food and Cosmetics	04/17/2023	Hazard analysis written
Macri Italian Bakery	Food and Cosmetics	04/17/2023	Hazard analysis biological, chemical, physical
Macri Italian Bakery	Food and Cosmetics	04/17/2023	Verification activity - appropriate
Macri Italian Bakery	Food and Cosmetics	04/17/2023	Verification activity before import, periodically
Pepperidge Farm South Bend, IN Bakery Depot	Food and Cosmetics	09/29/2023	Grounds
Pepperidge Farm South Bend, IN Bakery Depot	Food and Cosmetics	09/29/2023	Plant construction and design
Single Source Medical, LLC.	Devices	12/06/2023	Lack/Inad procedure-Monitoring/Control of Validated Proces
Single Source Medical, LLC.	Devices	12/06/2023	Lack of or inadequate procedures - Acceptance activities
Single Source Medical, LLC.	Devices	12/06/2023	Lack of or inadequate procedures
Single Source Medical, LLC.	Devices	12/06/2023	Lack of or inadequate complaint procedures
South Bend Medical Foundation, Inc.	Biologics	09/01/2023	SOPs for investigations, records