Norwich Pharmaceuticals, Inc. – FDA EIR, Feb 9, 2018

An FDA inspection of Norwich Pharmaceuticals, Inc., located in Norwich, NY, was conducted from February 5-9, 2018. This audit was a directed post-approval inspection for ANDA 204621 (Nevirapine Extended Release 400mg tablet) and a limited Good Manufacturing Practice (GMP) review, in accordance with Compliance Programs 7346.843 and 7356.002. While no formal objectionable observations were issued via a Form FDA 483, several verbal observations highlighted areas needing improvement. Key issues included a lack of established procedures for continuous process verification to ensure manufacturing remains in a state of control, and insufficient quality control monitoring of supplier variability for raw materials such as Nevirapine. Additionally, concerns were raised regarding the potable water system used for equipment cleaning, which lacked microbial specifications and had not undergone a Performance Qualification since its 1996 validation. The firm also lacked adequate cleaning validation studies to prove the effectiveness of its Nevirapine equipment cleaning processes against specific microbial contaminants. Management was made aware of these findings, and the company is undertaking a voluntary corrective action (CAPA-00001-2018) to enhance continuous improvement monitoring and supplier qualification, addressing aspects of the regulatory framework.