FDA EIR - WelchDry, Inc - March 17, 2022

A routine Current Good Manufacturing Practice (cGMP) inspection of WelchDry, Inc., a contract manufacturer of active pharmaceutical ingredients (APIs) and other products, was conducted by the FDA in Holland, MI, from March 15 to March 17, 2022. The inspection was performed under Compliance Program 7356.002F, focusing on Active Pharmaceutical Ingredient Process Inspection, and assessed the firm's quality, facilities, equipment, and production systems. Although no official inspectional observations were issued, and the inspection was classified as "No Action Indicated," several deficiencies were verbally discussed with management. These included the need to strengthen the annual cGMP training program, enhance environmental monitoring and water testing programs (especially point-of-use water testing for cleaning purposes), improve processing suite and equipment status placards, and maintain better cleaning agent preparation and testing records—a repeat issue from a prior inspection. The FDA also advised WelchDry to verify that their contract laboratories maintain active FDA registrations and adhere to validated testing procedures and good laboratory practices. WelchDry management acknowledged these deficiencies and committed to implementing corrective actions.