FDA EIR - The Dow Chemical Company - July 06, 2015

An FDA inspection was conducted at The Dow Chemical Company's Midland, MI facility on July 6, 2015. This was a scheduled visit to an out-of-cycle drug firm, identified as a contract manufacturer of Active Pharmaceutical Ingredients (APIs), following the regulatory framework outlined in CP7356.002F. The previous inspection, completed in 2012, had classified the facility as compliant. However, the primary finding of the 2015 inspection was that The Dow Chemical Company had ceased all pharmaceutical operations at this site on February 4, 2013. The last batch of Sevelamer HCl, the API previously manufactured, was produced on that date. The company had formally notified the FDA's Detroit District office of this shutdown in March 2013. During the inspection, the investigator confirmed the cessation of activities. The laboratory previously used for API testing had been cleared of all instrumentation, and no production activities were observed in the Sevelamer production building. Company personnel confirmed that all retain samples for Sevelamer HCl and Sevelamer Carbonate had been transferred off-site. Consequently, there were no main violations or issues identified, as pharmaceutical manufacturing had concluded over two years prior. The required action resulting from this inspection was a recommendation for the firm to be listed as "NOEI" (No Establishment Inspection), reflecting its inactive status as an API manufacturer. The production building is reportedly slated for future use by Dow AgroSciences LLC for agricultural chemicals.