Hovione LLC – FDA EIR, Dec 16, 2015

The FDA conducted a routine inspection of Hovione LLC, located in East Windsor, NJ, from December 3 to December 16, 2015. This inspection was part of the NWJ-DO FY16 Workplan, focusing on the company's compliance with current Good Manufacturing Practices (cGMP) for active pharmaceutical ingredients (APIs). The inspection followed guidance from several FDA documents, including CPGM 7356.002 and the Q7 Good Manufacturing Practice guidelines.

Hovione LLC, which operates as one of five global API manufacturing facilities under the Hovione brand, was previously inspected in April 2013 with no significant findings. During the 2015 inspection, the FDA identified several issues, including undefined timeframes for addressing unknown impurities, inadequate qualification activities after moving equipment, and unclear procedures for environmental monitoring. Additionally, the cleaning procedures for certain equipment did not fully address the range of materials handled.

A significant finding was the lack of controls in distributing laboratory worksheets, leading to the issuance of an FDA 483 form, which outlines inspectional observations. The company was required to respond in writing within 15 business days. No samples were collected during this inspection, and there were no refusals.

The inspection concluded with a closeout meeting attended by key management personnel, including Marco A. Gil, the General Manager. Hovione LLC committed to addressing the FDA's observations and maintaining compliance with regulatory standards. The firm's drug manufacturing registration remains current, and it continues to produce APIs for commercial, research, and clinical purposes.