FDA EIR - Nitto Denko Avecia Inc. - May 10, 2018

An FDA pre-approval inspection of Nitto Denko Avecia Inc., a contract manufacturer of advanced oligonucleotide products in Milford, MA, was conducted from April 25 to May 10, 2018. This inspection, performed under FDA Compliance Program 7346.832, focused on evaluating the firm's compliance with current Good Manufacturing Practices (ICH Q7 for Active Pharmaceutical Ingredients) for its active pharmaceutical ingredient (BAL). The assessment covered the company's Quality, Facilities & Equipment, Materials, Production, and Laboratory systems. At the inspection's conclusion, a one-item Form FDA 483, "Inspectional Observations," was issued. The primary finding highlighted an inadequate procedure for sampling critical raw materials. This observation requires Nitto Denko Avecia Inc. to address the deficiency in their material control processes. Firm management acknowledged the finding and formally committed to submitting a comprehensive written response to the Agency within 15 business days, outlining their proposed corrective and preventative actions.