Grand Rapids Reporter

There were five companies in cities associated with Kent 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 400% increase over the number of companies cited in the previous year.

The citations in the county include:

• Risk analysis is inadequate.
• Procedures have not been adequately established to control product that does not conform to specified requirements.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in either 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
Dennis Hammond	Devices	06/20/2023	Investigator non-compliance with agreement/plan/regulations
Dennis Hammond	Devices	06/20/2023	Record retention inadequate
IVF Laboratories of Grand Rapids, LLC	Biologics	04/27/2023	Identified as quarantined, distinguishable
Meijer #816 - Grand River Packaging, Inc.	Food and Cosmetics	09/06/2023	Hazard analysis - Identification of hazard
Michigan Reproductive and IVF Center, PLLC	Biologics	04/27/2023	Risk factors, clinical evidence
Michigan Reproductive and IVF Center, PLLC	Biologics	04/27/2023	Donors with risks not determined ineligible
SunMed Holdings, LLC	Devices	08/30/2023	Design Validation - Risk analysis not performed/inadequate
SunMed Holdings, LLC	Devices	08/30/2023	Nonconforming product, Lack of or inadequate procedures
SunMed Holdings, LLC	Devices	08/30/2023	Lack of or inadequate procedures