Kalamazoo Times

There were three companies in cities associated with Kalamazoo 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 an increase over the number of companies cited in the previous year.

Of the 18 citations issued, the most common citations include:

• The quality control unit lacks authority to review production records to assure that no errors have occurred.
• Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

All of the companies cited were involved in either Food and Cosmetics, Biologics, Drugs, or Devices 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
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Authority lacking to review records, investigate errors
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Buildings of Suitable Size, Construction, Location
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Cleaning System
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Sanitation--buildings not clean, free of infestation
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Equipment Design, Size and Location
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Absence of Written Procedures
Pharmacia & Upjohn Company, LLC	Biologics	06/16/2023	Validation lacking for sterile drug products
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Authority lacking to review records, investigate errors
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Buildings of Suitable Size, Construction, Location
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Cleaning System
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Sanitation--buildings not clean, free of infestation
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Equipment Design, Size and Location
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Absence of Written Procedures
Pharmacia & Upjohn Company, LLC	Drugs	06/16/2023	Validation lacking for sterile drug products
Stryker Corporation	Devices	01/24/2023	Design validation- Lack of or inadequate procedures
Stryker Corporation	Devices	01/24/2023	Lack of or inadequate complaint procedures
Water Street Coffee Joint	Food and Cosmetics	06/07/2023	Grounds
Water Street Coffee Joint	Food and Cosmetics	06/07/2023	Plant construction and design