Kingchem US manufacturing facility receives zero 483s after successfully completing US FDA cGMP surveillance inspection.

On November 14^th, 2024, the FDA conducted a cGMP surveillance inspection of Kingchem Laboratories (KLI) located in Saint Francis, Wisconsin. After the inspection, the FDA determined that Kingchem’s facility has no action indicated (NAI). Kingchem Laboratories remains in good standing with the FDA and is in an acceptable state of compliance to continue cGMP manufacturing for our customers.

Michael Ayeni, Kingchem’s Director of Quality and Regulatory Affairs, commented that “the recent NAI cGMP Surveillance Inspection by the FDA is a testament to KLI’s focus on making sure that Quality is an essential element built into our manufacturing process, assuring a quality product that is safe for use and that has the ingredients and strength it claims to have.”

Furthermore, he added that “we continuously identify opportunities for improvement and implement those enhancements to strengthen our Quality Management System in all areas beyond minimum requirements.”

Kingchem is proud to receive the no action indicated result which means that there were zero 483 observations. The recent FDA cGMP Surveillance Inspection is a testament to Kingchem’s commitment to a perpetually audit-ready facility. Kingchem’s customers rely on Kingchem for pharmaceutical manufacturing, making life saving medications.

Ryan Yoder, PhD, Kingchem’s Senior Vice President of Business Development, discusses the results of the audit.

“The successful FDA audit at Kingchem’s US cGMP manufacturing facility is great news for our current customers that trust us to handle their APIs and cGMP intermediates through all stages of clinical trials as well as those that have successfully been commercially launched. We are proud to share this result with potential customers as one example of Kingchem’s commitment to setting the highest standards for our facilities both in the US and globally.”

Kingchem is a global chemical manufacturer focused on active pharmaceutical ingredients, intermediates, and excipients. The Kingchem facility in Saint Francis, Wisconsin is Kingchem’s first US manufacturing facility, which was acquired in 2018. Since the acquisition Kingchem has invested heavily in production equipment and personnel to modernize the facility and respond to strong demand for US manufacturing of pharmaceutical products. Kingchem very recently commissioned a brand-new state of the art cGMP kilo-lab among other capital project investments at the site.

Description of the audit process from the FDA.

“FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new and generic drug marketing applications includes a review of the manufacturer’s compliance with the CGMP. FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.”

For more information on the FDA audit process please visit the FDA website.

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